Class I - Dangerous
Potential for the sterility barrier to be compromised.
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Other Medical Devices
🏥 Medical Devices • 15,809 recalls
Philips Easy Diagnost Product Usage: Stationary Fluoroscopic system
Philips Healthcare
Class I - Dangerous
If a lead ruler is not positioned in the same plane as the anatomical image detail to be measured, measured object distances (using the ruler) can be wrong by a corresponding factor. If, additionally, the measurement tool is not used to check the ruler, or is used in the right way (ie: calibration), such calibration error is not detected. As a result of this, a surgical intervention may be execut
Class I - Dangerous
Potential for the sterility barrier to be compromised.
SPECIALTYCARE - HUDGENS. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
Terumo Cardiovascular Systems
Class I - Dangerous
During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannulae connectors. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface, the substance was likely deposited during the molding process, but the exact composition of the parti
Class I - Dangerous
Potential for the sterility barrier to be compromised.
Philips is issuing a software update (version 3.2.4) to the Brilliance iCT and iCT SP systems currently running software version 3.2.0, 3.2.1 or 3.2.3, addressing a number of non-conformances. A review was conducted of all nonconformances that are fixed by the software upgrade. None of these nonconformances result in unacceptable hazards. The nonconformance documented below had the highest sc
Class I - Dangerous
An incident was reported that an operator's finger was pinched between the fixed roller and the gliding tabletop of a Proteus XR/a Table while moving the tabletop with the thumb placed over its edge and fingers underneath
Philips Healthcare Practix Convenio Mobile X-ray system Worldwide Distribution -- Nationwide
Philips Healthcare
Class I - Dangerous
When the system is switched off or when the tube arm is parked in the down position (X-ray generator switch off), a radiation pulse (50 kV, 2.5 pGy) is generated inadvertently. .When the system is switched off or when the tube arm is parked in the down position (X-ray generator switch off), a radiation pulse (50 kV, 2.5 pGy) is generated inadvertently. The failure happened when component supplie
Class I - Dangerous
Potential failure in the glued seal between the stem and the tip of the handpiece leading to the possible leakage of a very small drop of distilled water coolant from the handpiece in use.