Recall MonitorHealth Products
Philips Allura Xper Systems
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Radiology
Product: Philips Allura Xper Systems
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Allura Xper FD10 | Not applicable. | ALLURA XPER FD10 |
| Allura Xper FD10 | Not applicable. | 001443 |
| Allura Xper FD10 (Product Of AlluraClarity Family) | Not applicable. | 722026 |
| Allura Xper FD20 (Product Of AlluraClarity Family) | Not applicable. | 722028 |
| Allura Xper FD20/10 (Product Of AlluraClarity Family) | Not applicable. | 722029 |
| Allura Xper FD20/15 | Not applicable. | 722058 |
| Allura Xper FD20 OR Table (Product Of AlluraClarity Family) | Not applicable. | 722035 |
| Allura Xper FD20/20 (Product Of AlluraClarity Family) | Not applicable. | 722038 |
| Allura Xper FD10/10 (Product Of AlluraClarity Family) | Not applicable. | 722027 |
Issue
Philips has identified a software issue that may cause the Flexvision software application to become unresponsive during clinical use. When this occurs, the FlexVision monitor may either:• turn blank and no longer display live images or other information shown on the FlexVision monitor; or• freeze on the last displayed screen and no longer update live images or other information shown on the flexvision monitor.A cold system restart is required to restore normal FlexVision display functionality.