Official recall notice
FDA DeviceClass IINotable
Achieva XR Recall (Sep 2026) – Philips
Product: Achieva XR; Model Numbers (REF): 1. 781153, 2. 781253;
- Recall date
- 2026-09-30
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.
Product description
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.
Affected products
1. Model Numbers (REF): 781153; UDI-DI: N/A; Serial Numbers: 23035, 23003, 23021, 23028; 2. Model Numbers (REF): 781253; UDI-DI: N/A; Serial Numbers: 35028, 35068, 35083, 35074, 35049, 35004, 35006, 35011, 35015, 35050, 35076;