Angiographic X-ray
Azurion Recall Summary Philips Medical Systems Nederland BV is recalling Azurion products distributed to hospitals, pharmacies, and laboratories in New Zealand. The manufacturer will be issuing guidance on how to use these products. This is classified as a Class I recall, the most serious type.
- Recalling firm
- Philips New Zealand Commercial Limited
- Product
- Angiographic X-Ray. [Device]. Model: Philips Azurion and Allura Systems; Philips Azurion. Also covers: Azurion
- Reason
- The manufacturer has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch due to:, · Intermittent or absent electrical contact when the foot switch pedal is pressed due to gradual formation of silicon oxide layers on the microswitch1 contact surfaces., · Internal damage to the foot switch cable., · Application of strain relief2 on the connector that may not fully mitigate mechanical load, which could potentially result in connector damage and/or intermittent or complete loss of connection.
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-03-26
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/93e23d56-e41a-44aa-8a1b-ab9c4d09a70b