Z-0351-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 9, 2015
- Initiation Date
- February 3, 2015
- Termination Date
- January 18, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16 units
Product Description
Philips Healthcare Xper cardio systems Model : 722123 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
Reason for Recall
Monitor Ceiling Suspension system may fall
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.
Code Information
S/N: 3490 3056 3298 3249 3338 3354 3297 3394 3313 3429 3421 3434 3430 3430 3461 3487