Search

Maquet Cardiopulmonary Gmbh has determined during the testing of a Cardiohelp-I, that the cylindrical pin in the upper part of the transport guard can come loose. the transport guard is an accessory of the Cardiohelp-I and secures the oxygenator to the…

As a result of Shimadzu investigation, it was determined that there is an issue with the adjustment procedure documented for the calibration of the system x-ray generator. This could cause x-ray radiation dose rate to exceed regulation and/or standards…

If the Carescape Central Station v2.0 is used with an unapproved keyboard that contains a mute key, and if the mute key is pressed, the audio will be muted resulting in loss of audible alarms. this issue can result in a delay in noticing a change in…

During verification testing, a non-conformance was detected. Failure mode was uncontrolled leakage of glue from the distal tip of the Fix8 open (FX002) device. Recall start date: Feb 3, 2022

Revision D of recall: As a result of eight (8) customer complaints since revision A of this recall, a malfunction with the system controller module used in the Bio-Console 560 was identified. The malfunction is a result of the DC-DC converter and D88…

The manufacturer reported a fluid leak within the Benchmark Ultra instruments that created an electrical short on the instrument's general purpose input/output (GPIO) board's printed circuit board (PCB). The event was localized to the J1 connector of the…

Hillrom has received complaint reports of the Liko traverse carriers being delivered with the incorrect mounting bolts. The bolts are used to assemble the secondary rail with the traverse rail carrier. If approved installation procedures are not followed…