Philips Mr Systems With Sw Versions R5 & R11 - Ingenia, Achieva Series

Recalling firm
Philips New Zealand Commercial Limited
Product
Philips MR systems with SW versions R5 & R11 - Ingenia, Achieva Series. [Device]. Model: Ingenia Elition X, Ingenia Elition S, Ingenia 1.5T, SmartPath to dStream for 1.5T. Affected: Model numbers - 781358, 781357, 781341, 781260
Reason
The manufacturer has become aware of a software problem which may terminate an examination during the image reconstruction process. If the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory, the system will freeze, preventing image generation and requiring a system re-start., This problem can occur when the 3D Vane scan protocol is customised with a reconstruction matrix greater than 480 and/or more than 167 slices. Due to a system error in memory budgeting, the system may allow a scan to start even when there is not enough...
Classification
Class I
Category
medical device recall
Country
New Zealand
Agency
MEDSAFE
Recall date
2026-09-14
Status
Ongoing
Distribution
New Zealand - Hospital/Pharmacy/Laboratory

Official recall notice from MEDSAFE

Recall details on Nibble Recalls: https://trynibble.app/recalls/17993608-0c47-4b7a-a7d3-57358de8da66