Recall MonitorHealth Products
Allura Xper and Azurion Systems
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Radiology
Product: Allura Xper and Azurion 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 (Product Of AlluraClarity Family) | Not applicable. | 722026 |
| Allura Xper FD10/10 (Product Of AlluraClarity Family) | Not applicable. | 722027 |
| Azurion 7 M20 | Not applicable. | 722 224 |
| Azurion 7 M20 | Not applicable. | 722 079 |
| Azurion 7 M20 | Not applicable. | 722234 |
| Allura Xper FD20/15 | Not applicable. | 722058 |
| Allura Xper FD10 | Not applicable. | 001443 |
| Allura Xper FD20/10 (Product Of AlluraClarity Family) | Not applicable. | 722029 |
| Azurion 7 M12 | Not applicable. | 722233 |
| Azurion 7 M12 | Not applicable. | 722 223 |
| Azurion 7 M12 | Not applicable. | 722 078 |
| Azurion 3 M12 | Not applicable. | 722 063 |
| Azurion 3 M12 | Not applicable. | 722 221 |
| Azurion 3 M12 | Not applicable. | 722229 |
| Azurion 5 M12 | Not applicable. | 722 227 |
| Azurion 5 M12 | Not applicable. | 722231 |
| Azurion 5 M20 | Not applicable. | 722 228 |
| Azurion 5 M20 | Not applicable. | 722232 |
| Allura Xper FD20 (Product Of AlluraClarity Family) | Not applicable. | 722028 |
| Allura Xper FD20/20 (Product Of AlluraClarity Family) | Not applicable. | 722038 |
| Azurion 7 B20 | Not applicable. | 722 226 |
| Azurion 7 B20 | Not applicable. | 722236 |
| Azurion 7 B20 | Not applicable. | 722 068 |
| Azurion 3 M15 | Not applicable. | 722230 |
| Azurion 3 M15 | Not applicable. | 722 064 |
| Azurion 3 M15 | Not applicable. | 722 222 |
| Azurion 7 B12 | Not applicable. | 722 067 |
| Azurion 7 B12 | Not applicable. | 722235 |
| Azurion 7 B12 | Not applicable. | 722 225 |
| Allura Xper FD20 Or Table (Product Of AlluraClarity Family) | Not applicable. | 722035 |
Issue
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch due to: cable or connector damage (internal and/or external) internal microswitch failure (each foot switch pedal activates two independent microswitches that - when both activated - release X-ray) foot switch connector issues resulting from missing or incorrectly applied strain relief No or intermittent X-ray could potentially result in a delay or abort of procedure.