Medical device recalls

Distributed to the field without having completed design history files or design transfer activities

Distributed to the field without having completed design history files or design transfer activities

Distributed to the field without having completed design history files or design transfer activities

Distributed to the field without having completed design history files or design transfer activities

Distributed to the field without having completed design history files or design transfer activities

Distributed to the field without having completed design history files or design transfer activities

Distributed to the field without having completed design history files or design transfer activities

Distributed to the field without having completed design history files or design transfer activities

Distributed to the field without having completed design history files or design transfer activities

Distributed to the field without having completed design history files or design transfer activities

Distributed to the field without having completed design history files or design transfer activities

Distributed to the field without having completed design history files or design transfer activities

Distributed to the field without having completed design history files or design transfer activities

Distributed to the field without having completed design history files or design transfer activities

Distributed to the field without having completed design history files or design transfer activities

Distributed to the field without having completed design history files or design transfer activities

Artis systems containing a Multi Display Manager of a specific lot, the power distributor may lead to an increased electrical contact resistance or the interruption of electrical contact, and result in planned procedures to be terminated and performed on an alternative x-ray system

False positive results due to potential contamination of reagent.

The product is being recalled due to the central screw drill seizing inside the Comprehensive VRS Inserter, which may lead to an extension of surgery to find a replacement device.

The hemostasis valve of aspiration guide catheter devices may fail to seal resulting in a loss of vacuum during thrombus aspiration, which may result the procedure being prolonged as another device must be used or suboptimal thrombus removal if the problem is not detected.

False Positive results due to the MSSA (methicillin-susceptible) strain Staphylococcus aureus (ATCC 29213) breakthrough when this strain should have been inhibited.

In TSM (Treatment Session Manager) Motion Monitoring workflows, under certain conditions there can be a mismatch between the contour data overlay with respect to the motion monitoring images of the monitored structure.

There is an increased risk of false positive Proteus results when using the Film Array Blood Culture Identification Panel (BCID) in vitro diagnostic test of blood cultures used in conjunction with specific media types. False positive Proteus results from this test may lead to patients receiving improper antibiotic treatment until culture results are available (within 24-48 hours).

There is an increased risk of false positive Proteus results when using the Film Array Blood Culture Identification Panel (BCID) in vitro diagnostic test of blood cultures used in conjunction with specific media types. False positive Proteus results from this test may lead to patients receiving improper antibiotic treatment until culture results are available (within 24-48 hours).

Under certain conditions, a marble pattern infrequently appears on the monitor.

Under certain conditions, a marble pattern infrequently appears on the monitor.

Products repaired with the incorrect service manual may be missing an O ring and are subject to rework with the corrected service manual.

Firm has identified product has no staining. If used, may result in invalid test results when used with controls in the clinical setting. Positive control would observe no staining. The clinical impact may result in the consumption of patient tissue sample and a delay in diagnosis.

There is a risk for a false mutation positive result in rare cases resulting from a fluorescence artefact. In these rare cases, the controls pass correctly, while a fluorescence artefact in the mutation assay causes an incorrect valid mutation positive result.

potential risk that Legionella may be present in the Unity machine room, specifically the heat exchanger condensation collection tray.