Philips Medical Systems (Cleveland), Inc.

Entity profile compiled from public source records

Public Record Profile Registrations: 0 510(k) filings: 1 Recalls: 5

Known Identifiers & Locations

FEI Numbers 1525965
Owner Operator Numbers N/A
Locations Covered N/A

Registered Establishments (0)

No device registration and listing records found for this entity.

510(k) Premarket Notifications (1)

Submission # Device Name Decision Date Decision Description Action
K910715 VISTA HPQ SYSTEM 1991-06-07 Substantially Equivalent View Details

FDA Recall History (5)

Recall # Product Description Initiation Date Status Action
Z-0013-2007 Nuclear medicine systems: Gemini 16, Model 4535 679 28961. Gemini GXL, Models # 4535 679 71891, #4535 679 75681, #4535 679 75691. Precedence, Model #2169 -3000A, #2169-3001A, #2169-3002A, and 2169-3003A. PET/CT Computed tomography systems. Reason: A potential anomaly was identified on the CT subsytem, which could result in the radiation dose being different than the calculated dose reported to the operator. 2006-11-06 Terminated View Details
Z-0013-2014 Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology and Brilliance CT 16 (Air) Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology and Brilliance CT 16 (Air) scanners are whole body Computed Tomography X-ray systems that are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment supports, components and accessories. Reason: There are artifacts appearing on the Tracker images during threshold-triggered bolus scans with protocols using a Rotation Time of 0.4 seconds. 2013-08-30 Terminated View Details
Z-0014-2007 Brilliance(a) CT 6 slice, Model #4535 670 73191. Brilliance(a) CT 10 Slice, Model 4535 670 73181. Brilliance 16 Slice, Model #4535 670 78851. Brilliance CT 16 Power, Model #4535 670 23331. Brilliance CT 40 Slice, Model #4550 110 04011. Brilliance CT Big Bore, Model #4535 670 88051. Computed tomography systems. Reason: A potential anomaly was identified on the CT subsytem, which could result in the radiation dose being different than the calculated dose reported to the operator. 2006-11-06 Terminated View Details
Z-0019-2014 MX 16-Slice CT Scanner System. Used as a whole-body computed tomography X-Ray system. Reason: A pinch point at the end of the table top can cause injury. 2013-07-22 Terminated View Details
Z-0033-2014 Philips MR Systems: Asset 0.5T, Apollo 0.5T, Infinion 1.5T, Eclipse/Polaris 1.5T, Panorama 0.6T 1.0T, Magnetic Resonance Imaging Systems intended for clinical/radiologic diagnostic imaging applications. Reason: There is a potential for water to collect in the vent pipe elbow in the magnet venting system. Water may freeze, blocking the venting system. 2013-08-07 Terminated View Details

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