Recall MonitorHealth Products
Philips Allura Xper FD series
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Radiology
Product: Philips Allura Xper FD series
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 FD20 (Product Of Alluraclarity Family) | Not applicable. | 722028 |
| Allura Xper FD20/20 (Product Of Alluraclarity Family) | Not applicable. | 722038 |
| Allura Xper FD20/15 | Not applicable. | 722058 |
| Allura Xper FD10 (Product Of Alluraclarity Family) | Not applicable. | 722026 |
Issue
Philips has identified a potential safety issue affecting Allura R8.2 systems equipped with a AD7x patient table type potentially leading to loss of geometry movements. In some cases, following a system (re)start, manual and motorized geometry movements may be disabled due to a firmware issue in the Advanced Motion Controller (AMC) single-axis motion control unit used in the AD7x tables of Allura R8.2 systems. When the issue occurs, no message is displayed to the user. In this situation, X-ray imaging is available. The issue can be resolved by performing a cold restart of the system or by restarting the geometry.