Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 19640 |
| Brand Name: | Philips Ingenuity CT System |
| Model: | 728326 |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Philips New Zealand Commercial Limited Level 3 123 Carlton Gore Road Newmarket AUCKLAND 1023 |
| Contact Information: | 0800 251 400 |
| Manufacturer: | Philips Medical Systems |
| Issue: | During manufacturing Philips identified an issue involving hydrogen embrittlement of fasteners used in the manufacture of CT systems. It was determined this was due to trapped hydrogen introduced into the fastener during electroplating operations performed by a Philips supplier. Hydrogen embrittled fasteners can crack and fail suddenly when under stress. Assessment of these fasteners determined that sufficient mitigations were in place such that a single-point failure did not exist. Even should two fasteners fail for the same component, the occurrence of harm was determined to be less than remote. There have been no complaints associated with this issue, and no reports of injury or death. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 20/1/2016 |
