Angiographic X-ray
- Recalling firm
- Philips New Zealand Commercial Limited
- Product
- Angiographic X-Ray. [Device]. Model: Azurion 7 M20; Azurion 7 M20. Affected: System code: 722079; System code: 722224. Also covers: [MDR] Azurion
- Reason
- The manufacturer identified that, during certain repair or service activities on Azurion systems, SSDs not specified in the Medical Device File may have been installed. These SSDs may have different performance characteristics and potentially reduced reliability over time. If an affected SSD fails to perform as intended, this may result in loss of imaging or motorised movement functionality, a blank/black display, inability to store newly acquired images, or inability to access previously acquired images.
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-10-28
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/2daf35b0-5b00-4db6-8a99-eec8a3cb27de