Philips Allura And Azurion Systems
Philips is recalling Allura and Azurion Systems that were distributed to hospitals, pharmacies, and laboratories in New Zealand. These medical imaging systems are being recalled so they can be exchanged for replacements. The FDA classified this as a Class I recall, which is the most serious type.
- Recalling firm
- Philips New Zealand Commercial Limited
- Product
- Philips Allura and Azurion Systems. [Device]. Model: Azurion 7 B20, Azurion 7 M12, Azurion 7 M20. Affected: Models number - 722068, 722078, 722079
- Reason
- The manufacturer identified that the deaeration hose in CU3101 X-ray tube cooling units (manufactured February 2016–May 2020) may degrade over time, leading to oil leakage and reduced cooling performance. If oil flow drops below a threshold, the system automatically switches to low-dose fluoroscopy with a tube cooler error message, which cannot be resolved by restarting. Leaked oil is usually contained within the system, but in rare cases may escape, contact hot surfaces, and generate fumes that can activate environmental detection systems.
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-05-04
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/501b2e21-defa-4d04-aba8-5642a074c7ac