🏥 Medical Devices • 15,809 recalls
In these units, the brake is usually released by gripping the drive handle and applied by letting go of the handle. However, for systems within a specified manufacture period, we have identified that even when letting go of the handle, the systems brakes are not applied. In this event, if the Operator releases the handle when the device is moving, the unit will continue to coast.
An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.
Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium pin label mistakenly lists ceramic tip. The second line description should state titanium pin.
The software in the systems may not process the cycle originally intended. This could result in damage to the various medical devices and instruments processed in the washer/disinfector or potential for inadequate cleaning or disinfection.
Reckitt Benckiser
Five batches of the product have failed the specification of 1.0kPa for Burst Pressure.
Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium pin label mistakenly lists ceramic tip. The second line description should state titanium pin.
Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium pin label mistakenly lists ceramic tip. The second line description should state titanium pin.
The software in the systems may not process the cycle originally intended. This could result in damage to the various medical devices and instruments processed in the washer/disinfector or potential for inadequate cleaning or disinfection.
Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium pin label mistakenly lists ceramic tip. The second line description should state titanium pin.
Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium pin label mistakenly lists ceramic tip. The second line description should state titanium pin.
Linet Spol. S.r.o.
LINET has recently become aware of a potential safety issue for the AVE 2 Birthing Bed caused by the power cable breaking at the bed connection or the orange insulation of the power cable may fail causing a possible spark or possible exposure to a live conductor.
Five batches of the product have failed the specification of 1.0kPa for Burst Pressure.
Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium pin label mistakenly lists ceramic tip. The second line description should state titanium pin.
Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium pin label mistakenly lists ceramic tip. The second line description should state titanium pin.
Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium pin label mistakenly lists ceramic tip. The second line description should state titanium pin.
Maquet Cardiovascular
Potential lack of carbon dioxide (CO2) flow that may result in a procedural delay during off-pump coronary artery bypass (OPCAB).
RVO 2.0
During a post approval study the firm found there was an increased risk of corneal haze following the implantation of this device.
Abbott Laboratories
Abbott internal testing has identified that the Magnesium urine application demonstrates depressed urine result recovery. All samples >0.5mEq/L fail the linearity acceptance criteria for the bias specification and demonstrate depressed recovery of up to 37%. The specific cause of the negative bias/depressed results is currently under investigation.
The firm is recalling their Delta family of patient monitors software due to cybersecurity vulnerabilities, which may cause the device to reboot, lose functionality, and/or lose communication.
Siemens Medical Solutions USA
The swivel arm holding the monitors may become dislodged from the carrying arm.