Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 37291 |
| Brand Name: | Getinge Assured Batch Monitoring PCD |
| Model: | Model number - PL589/ 6005500575 |
| Affected: | 54043A |
| Software version: | |
| Recalling Organisation: | Getinge Australia Pty Ltd (NZ) Unit D, Ground Floor, Building A, Millenium Centre 600 Great South Rd Ellerslie Auckland 1051 |
| Contact Information: | 09 272 9039 |
| Manufacturer: | SteriTec Products Inc |
| Issue: | This problem was initiated by a customer product complaint regarding a missing O-ring. There have been no reported testing failures or adverse events, and the defect is unlikely to cause harm to the user. 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. |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 17/8/2026 |
