All Recalls

A gluing step was not performed during the manufacturing of the affected device's insertion tube. There is a potential for the insertion tube to develop a leak, which poses an infection control risk.

There is potential for packaging defects that may impact the sterile barrier.

The SARS-CoV-2 Process Control (Pellet) contains RNA transcripts that include diagnostically relevant SARS-CoV-2 targets (CDC and WHO consensus sequences).

Image acquisition failures and synchronization failure with the Centricity Enterprise Archive

There is potential for packaging defects that may impact the sterile barrier.

Software versions may result in sporadic problems causing scanning workflow interruptions and unexpected user notifications. Sporadic software errors may also occur during interventional workflows, resulting in delay in diagnosis or scan aborts with the necessity for patient rescan may occur

Customers have reported an increased number of false positive SARS-CoV-2 results.

A thin wall condition between the inner cannulation and the flutes of the drill which potentially could cause a fracture through the wall of the drill to the cannulation beneath.

Potential for a wire protrusion through the left heart vent catheter tip

Malfunction- loosening of the implant resulting in a potential revision surgery

Malfunction- loosening of the implant resulting in a potential revision surgery

There is potential for packaging defects that may impact the sterile barrier.

Malfunction- loosening of the implant resulting in a potential revision surgery

There is potential for packaging defects that may impact the sterile barrier.

There is potential for packaging defects that may impact the sterile barrier.

There is potential for packaging defects that may impact the sterile barrier.

There is potential for packaging defects that may impact the sterile barrier.

The device includes the incorrect Instructions for Use.

Sterility assurance may be compromised.

Malfunction- loosening of the implant resulting in a potential revision surgery