BostonSight SCLERAL 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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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
37,779 Total Recalls
BostonSight PROSE Lens.
Boston Foundation For Sight
Class I - Dangerous
Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both.
Class I - Dangerous
The products may contain surface and subsurface contamination of Listeria monocytogenes.
Class I - Dangerous
The DFPM yoke assembly ("yoke assembly") may detach from the spring arm. Should the yoke assembly detach from the spring arm, the yoke assembly would not be expected to fully detach but rather hang from the wiring within the yoke assembly.
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.
LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894K (6-pack), 2) REF 0894P (2-pack)
Microbiologics
Class I - Dangerous
KWIK-STIK REF numbers: 0894P, 0894K and LYFO DISK" 0894L may result in failure to recover the target microorganism. All lots of REF 894-76 are impacted.
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.
There is the potential that the silicone implant may contain foreign material
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.
The Drill stop kit contains incorrect components.
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.
The potential for risk of microbiological contamination of products due to inability to ensure sterility assurance throughout aseptic manufacturing.
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.