| Z-0001-2009 |
NeuViz Dual Multi-Slice Computed Tomography (CT) Scanner System (software).
Whole body x-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system software is an interactive program used for x-ray scan control, image reconstruction, and image archive/evaluation. It is intended to produce cross-section images of head and body by computer reconstruction of x-ray transmission data taken at different angles. The function of Time Scan is intended to use in contrast scan include single phase and multi-phase scan, that is according to different density of contrast in vessels or organs between different phase to get necessary information to support doctor's diagnosis.
Reason: An issue associated with the "Timed Scan" application was found. The system does not wait for the programmed time interval and starts the x-ray after selection of the scan button when certain criteria is met.
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2008-04-10 |
Terminated
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| Z-0012-2011 |
Essenta DR is a digital multifunctional X-ray systems, suitable for all routine radiographic exams, including specialist areas like trauma or pediatric work, excluding mammography.
It is designed for radiographic examination of the standing or seated patient or the recumbent patient in combination with a mobile X-ray table (trolley).
The intended use is from direct digital imaging using the built in flat panel detector and in addition for free exposures on radiographic cassettes.
Reason: When a patient is selected in the patient list and examination tab pressed with background query running at the same time, the wrong patient may be selected.
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2008-08-15 |
Terminated
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| Z-0021-2011 |
The BABIX holder is an accessory used with the BuckyDiagnost X-ray system. It is used to hold the baby either in a secured or immobilized standing position in front of the X-ray detector during the examination.
Reason: Potential of broken strands in the main steel cable supporting the accessory holder used with BuckyDiagnost and DigitalDiagnost X-ray systems.
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2010-09-09 |
Terminated
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| Z-0022-06 |
Interis Allura BiPlane X-Ray System
Reason: 1) During positioning of the Lateral Stand the rotation and/or skew movement may travel unexpectedly in opposite direction; 2) movement may be faster than normal speed; 3) the stand may not stop immediately upon release of the joystick.
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2005-07-27 |
Terminated
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| Z-0022-2011 |
The BABIX holder is an accessory used with the DigitalDiagnost X-ray system. It is used to hold the baby either in a secured or immobilized standing position in front of the X-ray detector during the examination.
Reason: Potential of broken strands in the main steel cable supporting the accessory holder used with BuckyDiagnost and DigitalDiagnost X-ray systems.
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2010-09-09 |
Terminated
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| Z-0034-2011 |
The device's marketing brochure states: "IntelliVue M3150 Information Center...Philips Medical Systems".
The beige-colored PAS-210 external speakers can be identified by their use of DB15-to-3.5 mm mini-phone jack cable (Agispec-081Y-4 or Agispec-081-6) to connect to the rp5700 PC.
Indicated for central monitoring of multiple adult, pediatric, and neonatal patients.
Reason: Potential for Internal Sound Amplifier to malfunction which could delay treatment.
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2008-11-21 |
Terminated
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