Device product
Philips Allura Xper FD20 system with an ADN7NT patient table. Model Number: 722012, Software Version Number 8.1.100.
Z-1895-2024
Product summary
- Event
- Event 94647
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1 unit (US)
- Official record key
device-enforcement:Z-1895-2024
Official wording
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.
Code information: Product number: 722012, UDI/DI: 00884838059054; Serial Number: 2138.
Distribution pattern: Domestic: OK International: India, Spain, U.A.E.
Derived failure modes
-
Unknown
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.