Philips Healthcare INTEGRIS cardio system Model : 722121 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
This recall has been terminated (originally issued February 3, 2015).
- Company
- Philips Medical Systems, Inc.
- Recall Initiated
- February 3, 2015
- Terminated
- January 18, 2017
- Recall Number
- Z-0348-2016
- Quantity
- 8 units
- Firm Location
- Andover, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Monitor Ceiling Suspension system may fall
Distribution
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.
Lot / Code Info
S/N: 1656 1667 1687 1668 1669 1670 1671 1685
Root Cause
Process control
Action Taken
Philips sent an Urgent Field Safety Notice letter dated January 8, 2015 to affected customers. The letter identified the affected product, problem and actions to be taken. The actuator of all affected systems will be replaced free of charge. All affected customers will be contacted in order to schedule the implementation of this action. For questions contact your local Philips representatice: Technical Support Line: 1-800-722-9377.