Recall MonitorHealth Products
Philips Ingenia, Achieva and Intera MR Systems
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Radiology
Product: Philips Ingenia, Achieva and Intera MR Systems
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additionl information.
Audience: Healthcare
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Ingenia 1.5T | Not applicable. | 781315 |
| Ingenia 1.5T | Not applicable. | 1.5T |
| Ingenia 3.0T CX | Not applicable. | 781271 |
| Achieva 1.5T MRI System - Main Unit | Not applicable. | ACHIEVA 1.5T |
| Achieva 3.0T MRI System - Main Unit | Not applicable. | ACHIEVA 3.0T |
| Ingenia Ambition S | Not applicable. | 782108 |
| Ingenia Ambition S | Not applicable. | 782139 |
| Ingenia 3.0T | Not applicable. | 3.0T |
| Ingenia Ambition X | Not applicable. | 782109 |
| Ingenia Ambition X | Not applicable. | 781356 |
| Ingenia Ambition X | Not applicable. | 782138 |
| Ingenia Elition X | Not applicable. | 782107 |
| Ingenia Elition X | Not applicable. | 781358 |
| Intera 1.5T MRI System - Main Unit | Not applicable. | INTERA 1.5T |
Issue
Philips has become aware of a software issue affecting Philips Magnetic Resonance (MR) imaging systems operating with software versions R5 & R11, 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.