Z-0354-2016 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
- 22 units
Product Description
Philips Healthcare Xper vascular systems R7.6 Model : 722134 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: 201 261 262 274 267 284 260 308 265 276 265 278 269 266 266 282 248 323 263 322 168 325