BostonSight PROSE Lens.
Boston Foundation For Sight
Class I - Dangerous
Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both.
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Other Medical Devices
🏥 Medical Devices • 15,203 recalls
Class I - Dangerous
The products may contain surface and subsurface contamination of Listeria monocytogenes.
SmartPath to dStream for 3.0T Model Number (REF): 782145;
Philips North America
Class I - Dangerous
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
Class I - Dangerous
Notice was issued to clarify flow rates related to the inlet fluid temperature.
Ingenia 1.5T S Model Number (REF): 781347;
Philips North America
Class I - Dangerous
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
Ingenia 3.0T Model Numbers (REF): (1) 781342, (2) 781377, (3) 782103;
Philips North America
Class I - Dangerous
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
Class I - Dangerous
Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
MR 5300 Model Numbers (REF): (1) 782110, (2) 782135 (China ONLY), (3) 782152;
Philips North America
Class I - Dangerous
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
Ingenia Ambition S Model Numbers (REF): (1) 781359, (2) 782108, (3) 782133 (China ONLY), (4) 782139;
Philips North America
Class I - Dangerous
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
Achieva 3.0T; Model Numbers (REF): (1) 781177, (2) 781277, (3) 781278, (4) 781344, (5) 781345;
Philips North America
Class I - Dangerous
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
Upgrade to MR 7700 Model Number (REF): 782130;
Philips North America
Class I - Dangerous
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
Ingenia 3.0T CX Model Numbers (REF): (1) 781271, (2) 782105;
Philips North America
Class I - Dangerous
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
Class I - Dangerous
The products may contain surface and subsurface contamination of Listeria monocytogenes.
Phasor Drill, REF: 2.70S, 3.20L, 4.50, 5.30, 6.35
Phasor Health
Class I - Dangerous
Drill for use in neurosurgical procedures may have a reverse battery orientation, which may increase surgical time.
Ingenia Elition S Model Numbers (REF): (1) 781357, (2) 782106, (3) 782137, (4) 782150 (China ONLY);
Philips North America
Class I - Dangerous
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
Achieva XR; Model Numbers (REF): (1) 781153, (2) 781253;
Philips North America
Class I - Dangerous
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
Class I - Dangerous
Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
SmartPath to Ingenia Elition X Model Numbers (REF): (1) 782118, (2) 782144;
Philips North America
Class I - Dangerous
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
Potential for temporary loss of imaging (X-ray) functionality due to software issue.
HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan¿ PAD (Public Access Defibrillator)
HeartSine Technologies
Class I - Dangerous
Due to a component manufacturing issue, Automated External Defibrillator may not function properly (deliver shocks)