Device product
Allura Xper FD20 R8.2 722028 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electrophysiology(EP).
Z-0924-2017
Product summary
- Event
- Event 75845
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2
- Official record key
device-enforcement:Z-0924-2017
Official wording
Reason: Due to a production error, screws were not tightened to specified torque. These screws may come loose from the C-arm shaft causing the C-arm to rotate uncontrolled.
Code information: 1000
Distribution pattern: US: WA OUS: China, Spain, Korea, Republic of, Germany
Derived failure modes
-
Manufacturing or process control
production error