Device product
Philips Healthcare Integris Allura 15 -12 Fluoroscopy x ray system
Z-0022-2015
Product summary
- Event
- Event 69197
- Status
- Terminated
- Classification
- Class II
- Quantity
- one system
- Official record key
device-enforcement:Z-0022-2015
Official wording
Reason: Philips had discovered through a field service testing where a device failed to comply with a Federal standard.
Code information: Model Number: Integris Allura 15-12 Serial Number: 16741023
Distribution pattern: US distribution to FL
Derived failure modes
-
Unknown
Philips had discovered through a field service testing where a device failed to comply with a Federal standard.