Allura Angiographic X-ray
- Recalling firm
- Philips New Zealand Commercial Limited
- Product
- Allura Angiographic X-Ray. [Device]. Model: System code: 722003 - Allura Xper FD10; System code: 722079 - Azurion 7 M20, System code: 722221 - Azurion 3 M12, System code: 722224 - Azurion 7 M20. Also covers: [MDR] Azurion
- Reason
- The manufacturer has identified through customer complaints that, during certain repair or service actions, HDDs with different performance characteristics than those specified by the legal manufacturer may have been installed. These HDDs may exhibit reduced reliability over time, which may result in loss of imaging functionality. Additionally, in Allura systems, this may lead to loss of motorised movement or loss of data., In addition, the manufacturer has identified that in some Allura systems, HDDs compliant with specifications but of different types have been used within a single...
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-07-02
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/c63eb856-f258-4639-9bc4-e4ee40c511bf