Device product
Philips Healthcare Xper vascular system Model : 722124 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, interventional procedures (such as PTCA, stent placement, embolization and thrombolysis and atherectomics), pacemaker Implantations and electrophysiology (EP). Use of the Allura Xper series system in the OR environment is restricted; the system should only be used for endo-vascular procedures. The Philips Integris Allura 9F is intended for diagnostic cardiovascular, vascular and interventional procedures
Z-0352-2016
Product summary
- Event
- Event 70370
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10 units
- Official record key
device-enforcement:Z-0352-2016
Official wording
Reason: Monitor Ceiling Suspension system may fall
Code information: S/N: 2653 2729 2853 2885 2695 2761 2670 2858 2846 2746
Distribution pattern: Worldwide Distribution - US Nationwide and the countries of: Canada,Australia, Austria, Brazil, Chile, China, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, South Africa, Spain, Switzerland and United Kingdom.
Derived failure modes
-
Unknown
Monitor Ceiling Suspension system may fall