| Reason for the Action |
Getinge has identified a problem with certain Getinge Assured Batch Monitoring PCD units, where the required O-ring was not installed during manufacture following a customer complaint.
The root cause was identified as a combination of a supplier production process failure and an internal quality inspection error.
Failure of the device, due to the missing O-ring, may state sterilisation cycle was not completed and may require re-sterilisation, which may disrupt workflow. This could result in delay of goods and, as such, delay of procedure; should this occur, it is anticipated that any procedural delays would be prior to administration of anaesthesia. |