Philips Mr Systems Ingenia, Achieva Series
- Recalling firm
- Philips New Zealand Commercial Limited
- Product
- Philips MR systems Ingenia, Achieva Series. [Device]. Model: Philips MR systems with SW version R11.1 and R12.1
- Reason
- The manufacturer has identified potential stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture, Archiving and Communication System (PACS)., The MRE viewer PACS indicates around 2 kPa (incorrect stiffness values), which can be associated with healthy tissue, while the general viewing environment in the MR Console viewer indicates almost 8 kPa (correct stiffness values), which can be an indicator of cirrhosis.
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-01-14
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/137ff198-532e-4acb-bbb6-5e193b84a62f