95,075 total recalls in our database
Philips North America
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 products may contain surface and subsurface contamination of Listeria monocytogenes.
Philips North America
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.
Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
Philips North America
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.
Fresenius Kabi USA
Potential for external cassette leaks
Reports of IVUS catheter and guide wire entanglement during radial-to-peripheral procedures, due to catheter use without appropriate sheath and/or guide catheter, which may require further intervention, such as surgical removal; Firm is restating instructions for use and adding: "Use a guide sheath of appropriate length to provide adequate support to the rapid exchange IVUS catheter and guidewire"
Potential for temporary loss of imaging (X-ray) functionality due to software issue.
HeartSine Technologies
Due to a component manufacturing issue, Automated External Defibrillator may not function properly (deliver shocks)
FUJIFILM Healthcare Americas
Devices had an unapproved slabbing software function enabled for use.
Philips North America
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.
Philips North America
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.
Philips North America
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.
Philips North America
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.
Philips North America
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.
Apic Yamada America
Apic Yamada has recently discovered that certain products may be out of compliance with FDA electronic product regulations in that they did not bear a required label.
LTS Therapy Systems
The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with the device.
Maquet Cardiopulmonary Gmbh
Device does not comply with the labeling requirements of international standard IEC 60601-1.
Philips North America
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.
LTS Therapy Systems
The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with the device.