Ingenia, Achieva Series

Recall Summary Philips Medical Systems is recalling certain MRI systems (Ingenia, Ingenia Elition, Ingenia Ambition, and MR 7700 models) distributed to hospitals, pharmacies, and laboratories in New Zealand. The systems require a software upgrade to address an unspecified issue. This is classified as a Class I recall, the most serious category.

Recalling firm
Philips New Zealand Commercial Limited
Product
Ingenia, Achieva Series. [Device]. Model: Philips MR systems with SW versions R11.1 and R12.1; MR systems operating on software versions R11.1 and R12.1. Also covers: Ingenia, Ingenia Elition, Ingenia Ambition, MR 7700 MRI Systems
Reason
26/05/2026: Update - The manufacturer has identified potential alignment errors in the cross-reference line functionality when reviewing images generated with the MobiView application., The manufacturer has identified potential alignment errors in the cross-reference line functionality when reviewing images generated with the MobiView application., A. The cross-reference line and/or box may be shown at an incorrect location when displayed on a MobiView generated image., The alignment errors may occur only if both of the following conditions are met:, Multi-station scans that require...
Classification
Class I
Category
medical device recall
Country
New Zealand
Agency
MEDSAFE
Recall date
2026-05-26
Status
Ongoing
Distribution
New Zealand - Hospital/Pharmacy/Laboratory

Official recall notice from MEDSAFE

Recall details on Nibble Recalls: https://trynibble.app/recalls/01fed788-b7b3-48cb-8c3e-09f047e819fb