PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Recall 94647
Description: Philips Allura Xper FD10 system with an ADN7NT patient table. Model Number: 722010, Software Version Number 8.1.100.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Recall 94647 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1896-2024 |
| Event ID | 94647 |
| Event Description | Philips Allura Xper FD10 system with an ADN7NT patient table. Model Number: 722010, Software Version Number 8.1.100. |
| Product Type | Devices |
| Distribution | Domestic: OK International: India, Spain, U.A.E. |
| Quantity | 3 units (OUS) |
| Recall Reason | When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the pivot brake does not engage. This issue may cause unexpected movements of the table. |
| Device Classification | 20240605 |
| Device Code Info | Product number: 722010, UDI/DI: 00884838059030; Serial Numbers: 774, 909, 526. |
| Center Classification Date | 20240524 |
| Recall Initiation Date | 20240516 |
| Recalling Firm | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Initial Notification | Letter |
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