Entity profile compiled from public source records
| Submission # | Device Name | Decision Date | Decision Description | Action |
|---|---|---|---|---|
| K203231 | Switched Internal Paddles | 2021-01-11 | Substantially Equivalent | View Details |
| Recall # | Product Description | Initiation Date | Status | Action |
|---|---|---|---|---|
| Z-0004-2023 | MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This is a component of product number 866162. Reason: Device may intermittently fail to produce audio. Turning the unit off and on does not resolve the issue; disconnecting and reconnecting to AC power does not reliably resolve the issue. | 2022-09-06 | Open, Classified | View Details |
| Z-0020-2025 | IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows: 1) IntelliVue MX400 866060; 2) IntelliVue MX450 866062; 3) IntelliVue MX500 866064; 4) IntelliVue MX550 866066 Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Reason: Devices with Option CP2 and initially programmed to software version P.01.01 were configured incorrectly at the factory. Therefore, Enhanced ECG Capabilities provided by Option CP2 were not enabled in these devices. Without Option C01 Full Arrhythmia, the device will not provide the yellow alarms for enhanced arrhythmia detection. This is a retrospectively reported recall from 6/14/23. | 2023-06-14 | Open, Classified | View Details |
| Z-0078-2022 | Philips, HeartStart FR2 + Defibrillator, Model # M3860A and M3861A Reason: Customers were not notified of previous recalls associated with various defibrillator models. | 2021-02-09 | Open, Classified | View Details |
| Z-0079-2022 | Philips, HeartStart FRx + Defibrillator, Model # Model #s: 861304 Reason: Customers were not notified of previous recalls associated with various defibrillator models. | 2021-02-09 | Open, Classified | View Details |
| Z-0080-2022 | Philips, HeartStart HS1 Home Defibrillator, Model # Model number: M5068A Reason: Customers were not notified of previous recalls associated with various defibrillator models. | 2021-02-09 | Open, Classified | View Details |
| Z-0081-2022 | Philips, HeartStart HS1 OnSite Defibrillator, Model #'s: M5066A and M5067A Reason: Customers were not notified of previous recalls associated with various defibrillator models. | 2021-02-09 | Open, Classified | View Details |
| Z-0213-2022 | Philips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.1.x, Model numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228. (Azurion 3 M12, Azurion 3 M15, Azurion 5 M12, Azurion 5 M20, Azurion 7 B12, Azurion 7 B20, Azurion 7 M12, Azurion 7 M20) Reason: When the user presses or releases both the APC (accept) button and the Float Tabletop (panning) button at the same time, the geometry may stop reacting on movement requests (table lock-up) and X-ray imaging becomes unavailable. | 2021-09-24 | Terminated | View Details |
| Z-0271-2024 | CombiDiagnost R90, Radiography and Fluoroscopy (R/F) system Reason: Potential for units suspended on the ceiling to fail and fall. | 2023-09-21 | Open, Classified | View Details |
| Z-0272-2024 | DigitalDiagnost 4 Chest/Emergency, used to acquire, process, store, display and export digital radiographic images. Reason: Potential for units suspended on the ceiling to fail and fall. | 2023-09-21 | Open, Classified | View Details |
| Z-0273-2024 | DigitalDiagnost 4 Flex/Value, used to acquire, process, store, display and export digital radiographic images. Reason: Potential for units suspended on the ceiling to fail and fall. | 2023-09-21 | Open, Classified | View Details |
| Z-0274-2024 | DigitalDiagnost 4 High Performance, used to acquire, process, store, display and export digital radiographic images. Reason: Potential for units suspended on the ceiling to fail and fall. | 2023-09-21 | Open, Classified | View Details |
| Z-0275-2024 | DigitalDiagnost C90 Flex/Value/Chest/ER, used to acquire, process, store, display and export digital radiographic images. Reason: Potential for units suspended on the ceiling to fail and fall. | 2023-09-21 | Open, Classified | View Details |
| Z-0276-2024 | DigitalDiagnost C90 High Performance, used to acquire, process, store, display and export digital radiographic images. Reason: Potential for units suspended on the ceiling to fail and fall. | 2023-09-21 | Open, Classified | View Details |
| Z-0277-2022 | Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - CT Vision ACQSIM CT System Number: 728209 Continuous CT (CCT) is a CT or PET/CT product option that enables physicians and radiologists to produce real-time CT images to facilitate image-guided surgery. Reason: Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Monitor Bracket Assembly detaching from the Suspension Arm, and resulting in injury to patient, operator, bystander, or service person located in the path of a falling part | 2021-05-01 | Open, Classified | View Details |
| Z-0277-2024 | DigitalDiagnost C90 Release 3, used to acquire, process, store, display and export digital radiographic images. Reason: Potential for units suspended on the ceiling to fail and fall. | 2023-09-21 | Open, Classified | View Details |
| Z-0278-2022 | Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini GXL 16 Slice System Number: 882410 Continuous CT (CCT) is a CT or PET/CT product option that enables physicians and radiologists to produce real-time CT images to facilitate image-guided surgery. Reason: Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Monitor Bracket Assembly detaching from the Suspension Arm, and resulting in injury to patient, operator, bystander, or service person located in the path of a falling part | 2021-05-01 | Open, Classified | View Details |
| Z-0278-2024 | DigitalDiagnost C90 Release 3.1, used to acquire, process, store, display and export digital radiographic images. Reason: Potential for units suspended on the ceiling to fail and fall. | 2023-09-21 | Open, Classified | View Details |
| Z-0279-2022 | Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - TruFlight Select PET/CT System Number: 882438 Continuous CT (CCT) is a CT or PET/CT product option that enables physicians and radiologists to produce real-time CT images to facilitate image-guided surgery. Reason: Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Monitor Bracket Assembly detaching from the Suspension Arm, and resulting in injury to patient, operator, bystander, or service person located in the path of a falling part | 2021-05-01 | Open, Classified | View Details |
| Z-0279-2024 | EasyDiagnost Eleva DRF, Release 5, used to acquire, process, store, display and export digital radiographic images. Reason: Potential for units suspended on the ceiling to fail and fall. | 2023-09-21 | Open, Classified | View Details |
| Z-0280-2022 | Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF 16 System Number: 882470 Continuous CT (CCT) is a CT or PET/CT product option that enables physicians and radiologists to produce real-time CT images to facilitate image-guided surgery. Reason: Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Monitor Bracket Assembly detaching from the Suspension Arm, and resulting in injury to patient, operator, bystander, or service person located in the path of a falling part | 2021-05-01 | Open, Classified | View Details |
| Z-0280-2024 | ProxiDiagnost N90, Radiography and Fluoroscopy (R/F) system Reason: Potential for units suspended on the ceiling to fail and fall. | 2023-09-21 | Open, Classified | View Details |
| Z-0281-2022 | Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF 64 System Number: 882471 Continuous CT (CCT) is a CT or PET/CT product option that enables physicians and radiologists to produce real-time CT images to facilitate image-guided surgery. Reason: Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Monitor Bracket Assembly detaching from the Suspension Arm, and resulting in injury to patient, operator, bystander, or service person located in the path of a falling part | 2021-05-01 | Open, Classified | View Details |
| Z-0284-2021 | Philips Sterilizable Defibrillator Paddles, Switched Internal Paddles, Model Numbers M4741A, M4742A, M4743A, M4744A - Product Usage: used in pairs to transmit a controlled electrical shock from an external defibrillator directly to the exposed heart muscle of a post-pubescent patient in order to intentionally stop start the heartbeat during cardiopulmonary surgery. Reason: The periodic Paddle Checks recommended in the Instructions for Use for Sterilizable Defibrillator Paddles may not detect one failure mode for the Switched Internal Defibrillator Paddles. Philips has created an addendum to the IFU, that includes a test for the switched paddles only, which will detect this failure mode. | 2020-09-14 | Terminated | View Details |
| Z-0285-2021 | Philips Sterilizable Defibrillator Paddles, Switchless Internal Paddles, Model Numbers M1741A, M1742A, M1743A, M1744A - Product Usage: used in pairs to transmit a controlled electrical shock from an external defibrillator directly to the exposed heart muscle of a post-pubescent patient in order to intentionally stop start the heartbeat during cardiopulmonary surgery. Reason: The periodic Paddle Checks recommended in the Instructions for Use for Sterilizable Defibrillator Paddles may not detect one failure mode for the Switched Internal Defibrillator Paddles. Philips has created an addendum to the IFU, that includes a test for the switched paddles only, which will detect this failure mode. | 2020-09-14 | Terminated | View Details |
| Z-0292-2024 | Big Bore RT with software version V4.8.0.10421- Model: 728242 CT scanner and simulator designed for radiation oncology and therapy. Reason: For oncology users: If the user performed off-set reconstruction on CT device a shift could be observed on the contouring area of the primary and secondary images sets when using image fusion (on TPS) and incorrect coordinates may be sent to TPS system when using absolute patient marking. This may lead to incorrect radiation therapy planning and possible growth or spread of cancer due to incorrect early treatment regimen. For radiology users: If the user performed off-set reconstruction on CT devices, after multiple acquisitions, the Relate Position could be inaccurate. This could lead to incorrect diagnosis and treatment. | 2023-10-09 | Open, Classified | View Details |
| Z-0293-2024 | Brilliance CT Big Bore with software version V4.8.0.10421 Model:728244 CT scanner and simulator designed for radiation oncology and therapy. Reason: For oncology users: If the user performed off-set reconstruction on CT device a shift could be observed on the contouring area of the primary and secondary images sets when using image fusion (on TPS) and incorrect coordinates may be sent to TPS system when using absolute patient marking. This may lead to incorrect radiation therapy planning and possible growth or spread of cancer due to incorrect early treatment regimen. For radiology users: If the user performed off-set reconstruction on CT devices, after multiple acquisitions, the Relate Position could be inaccurate. This could lead to incorrect diagnosis and treatment. | 2023-10-09 | Open, Classified | View Details |
| Z-0294-2024 | Brilliance CT Big Bore Oncology with software version V4.8.0.10421 Model:728243 CT scanner and simulator designed for radiation oncology and therapy. Reason: For oncology users: If the user performed off-set reconstruction on CT device a shift could be observed on the contouring area of the primary and secondary images sets when using image fusion (on TPS) and incorrect coordinates may be sent to TPS system when using absolute patient marking. This may lead to incorrect radiation therapy planning and possible growth or spread of cancer due to incorrect early treatment regimen. For radiology users: If the user performed off-set reconstruction on CT devices, after multiple acquisitions, the Relate Position could be inaccurate. This could lead to incorrect diagnosis and treatment. | 2023-10-09 | Open, Classified | View Details |
| Z-0355-2022 | BV Endura with Software Release 2.3- A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718075 Reason: Instructions for Use do not specify the maximum surface temperature of the X-ray tank (assembly housing the X-ray tube, beam filter & cooling oil) and the image intensifier/detector of the system as required an result in burns | 2021-11-12 | Open, Classified | View Details |
| Z-0356-2022 | BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095 Reason: Instructions for Use do not specify the maximum surface temperature of the X-ray tank (assembly housing the X-ray tube, beam filter & cooling oil) and the image intensifier/detector of the system as required an result in burns | 2021-11-12 | Open, Classified | View Details |
| Z-0357-2022 | Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. . Model Number: 718132 Reason: Instructions for Use do not specify the maximum surface temperature of the X-ray tank (assembly housing the X-ray tube, beam filter & cooling oil) and the image intensifier/detector of the system as required an result in burns | 2021-11-12 | Open, Classified | View Details |
| Z-0389-2024 | Achieva 1.5T Reason: Potential component failure in the Gradient Coil could product smoke and/or fire. | 2023-10-23 | Open, Classified | View Details |
| Z-0390-2024 | Achieva 1.5T Conversion Reason: Potential component failure in the Gradient Coil could product smoke and/or fire. | 2023-10-23 | Open, Classified | View Details |
| Z-0391-2024 | Achieva 1.5T Initial System Reason: Potential component failure in the Gradient Coil could product smoke and/or fire. | 2023-10-23 | Open, Classified | View Details |
| Z-0392-2024 | Ingenia 1.5T CX Reason: Potential component failure in the Gradient Coil could product smoke and/or fire. | 2023-10-23 | Open, Classified | View Details |
| Z-0393-2024 | Intera 1.5T Reason: Potential component failure in the Gradient Coil could product smoke and/or fire. | 2023-10-23 | Open, Classified | View Details |
| Z-0394-2024 | Intera 1.5T Power/Pulsar Reason: Potential component failure in the Gradient Coil could product smoke and/or fire. | 2023-10-23 | Open, Classified | View Details |
| Z-0395-2024 | SmartPath to dStream for 1.5T Reason: Potential component failure in the Gradient Coil could product smoke and/or fire. | 2023-10-23 | Open, Classified | View Details |
| Z-0416-2022 | Philips Allura Xper FD series with Software Version Number: 2.1.x- intended for Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. Model Number: 722005, 722006, 722008, 722010, 722012, 722013, 722025, 722026, 722027, 722028. Reason: Set screws securing the two gliding rods of the Extra Monitors (called 7th and 8th monitor) mounted on the Monitor Ceiling Suspension (MCS) can come loose, the Extra monitors might disengage from the Mounting Ceiling Suspension structure and fall down, may lead to patient, user or service engineer harm that may require medical intervention. | 2021-11-19 | Terminated | View Details |
| Z-0459-2023 | Philips Ingenia Elition S MR System, Model Numbers 781357, 782106, 782137 Reason: Gradient Coil may act as a heat source with a potential to produce smoke and/or fire. | 2022-11-22 | Open, Classified | View Details |
| Z-0460-2023 | Philips Ingenia Elition X MR System, Model Numbers 781358, 782107, 782119, 782136 Reason: Gradient Coil may act as a heat source with a potential to produce smoke and/or fire. | 2022-11-22 | Open, Classified | View Details |
| Z-0461-2023 | Philips SmartPath to Ingenia Elition X MR System, Model Numbers 782118, 782132, 782144 Reason: Gradient Coil may act as a heat source with a potential to produce smoke and/or fire. | 2022-11-22 | Open, Classified | View Details |
| Z-0462-2023 | Philips MR 7700 System, Model Number 782120 Reason: Gradient Coil may act as a heat source with a potential to produce smoke and/or fire. | 2022-11-22 | Open, Classified | View Details |
| Z-0463-2023 | Philips Upgrade to MR 7700 System, Model Number 782130 Reason: Gradient Coil may act as a heat source with a potential to produce smoke and/or fire. | 2022-11-22 | Open, Classified | View Details |
| Z-0471-2022 | Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2 with LUC configuration start-up issue; Azurion R2.2 emergency stop recovery issue Model Numbers: 722221, 722228, 722225, 722068, 722226, 722078, 722224 Reason: (1)Start-up problem: Intermittently at start-up of the system, the communication of the control unit that manages the movement of the stand is not established; (2) Emergency stop recovery problem-warm restart is not executed correctly and movement functionality is not available | 2021-11-12 | Terminated | View Details |
| Z-0476-2022 | Wireless Footswtich used with the following Philips Allura Xper and Azurion Interventional Fluoroscopic X-ray System . Model Number: 722001, 722002, 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722014, 722015, 722019, 722020, 722022, 722023, 722024, 722025, 722026, 722027, 722028, 722029, 722033, 722034, 722035, 722036, 722038, 722039, 722058, 722059, 722065, 722066, 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228. Wireless footswitch Models: 459801319471, 459801319521, 459801319361, 459801319421, 459801319481, 459801319531, 459801319511, 459801319541, 459801319371, 459801319431, 459801319391, 459801319441, 459801238241, 459801238231, 459801238261, 459801238251, 459801238201, 459801238191, 459801238221, 459801238211, 459801733051, 459801733061, 459801733071, 459801733081, 459801257861, 459801733091 Reason: Wireless foot switch connection issues causing interruption of Fluoroscopy and exposure | 2021-10-29 | Open, Classified | View Details |
| Z-0489-2018 | MRx Defibrillator Model # M3535A & M3536A, UDI 00884838000018(21)US00601969 Product Usage: The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician Reason: Affected units may have a defective component that is intended to protect the internal circuitry from high voltages during shock delivery. The defective component may also prevent delivery of shocks in AED mode. | 2017-07-12 | Terminated | View Details |
| Z-0498-2020 | HeartStart XL+ Defibrillator/Monitor, Model 861290 Reason: The rotary therapy selector switch may fail, resulting in unexpected device behavior. These behaviors include: The device may not turn on; The device may not perform the selected function; The device may deliver a shock with an energy level different from the setting selected by the user. | 2019-10-16 | Terminated | View Details |
| Z-0505-2022 | Infa-Therm Transport Mattress, Reference Number 989805616831 1015 Reason: After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modified labeling cannot be distributed or sold without new 510(k) clearance. | 2021-11-26 | Open, Classified | View Details |
| Z-0505-2024 | Panorama 1.0T HFO, Magnetic Resonance (MR) System; Model Numbers 781250 and 781350. Philips Magnetic Resonance (MR) systems are Medical Electrical Systems for use as a diagnostic device. Reason: Firm was informed of an event in which the structural integrity of the MR system components failed due to unintended excessive pressure buildup of helium gas during a magnet quench. If the system is unable to contain the pressured helium gas due to an unforeseen blockage in the system, risks to patients and/or operators that may lead to injury or death include chemical exposure (i.e. helium gas) that may expand to surrounding rooms, contusion caused by debris, and asphyxia. | 2023-11-17 | Open, Classified | View Details |
| Z-0506-2022 | Infant Heel Warmers w/strap, Reference # 989805603201 1223 Reason: After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modified labeling cannot be distributed or sold without new 510(k) clearance. | 2021-11-29 | Open, Classified | View Details |
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