🏥 Medical Devices • 15,203 recalls
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.
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.
Fresenius Kabi USA
Potential for external cassette leaks
Fresenius Kabi USA
Potential for external cassette leaks
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.
Due to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction.
Olympus Corporation of the Americas
Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
Olympus Corporation of the Americas
Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
CooperVision
Lens blisters may have an incomplete or leaking seal which may render them unsterile.
GE Medical Systems
GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99dB, the limit established by International Electrotechnical Commission (IEC 60601-2-33) when using hearing protection with a Noise Reduction Rating (NRR) of 29dB, as currently required in the Operator Manual.