Angiographic X-ray Allura Xper Fd20
Philips Medical Systems Nederland BV is recalling MultiDiagnost-Eleva systems that were distributed to hospitals, pharmacies, and laboratories in New Zealand. The affected systems will be exchanged as part of this recall action. This is classified as a Class I recall, which is the most serious type.
- Recalling firm
- Philips New Zealand Commercial Limited
- Product
- Angiographic X-Ray Allura Xper FD20. [Device]. Model: Allura Xper FD20 - Model - 722012; MultiDiagnost Eleva with Flat Detector - Model - 708038. Also covers: MultiDiagnost-Eleva systems
- Reason
- The manufacturer has observed occurrences in which the hand switch button, used for activating exposure from the control room, did not fully release after being pressed due to mechanical resistance within the button mechanism., The manufacturer has observed occurrences in which the hand switch button, used for activating exposure from the control room, did not fully release after being pressed due to mechanical resistance within the button mechanism., The hand switch has three mechanical positions:, 1) Neutral – the button is not pressed., 2) Prepare – the button is partially pressed...
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-06-08
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/2a392405-af92-48fb-8dd0-792e9bc2bfb8