Philips Expression MR200 MRI Patient Monitoring System
This recall has been terminated (originally issued October 15, 2014).
- Company
- Invivo Corporation
- Recall Initiated
- September 5, 2014
- Posted
- October 15, 2014
- Terminated
- October 12, 2017
- Recall Number
- Z-0069-2015
- Quantity
- 24 units.
- Firm Location
- Orlando, FL
- Official Source
- View on FDA website ↗
Reason for Recall
Failure to produce the Non-Invasive Blood Pressure (NIBP) Measurement.
Distribution
Worldwide Distribution - US including the states of CA, GA, MI, NJ, NV, and TX., and the countries of: Austria, Finland, Germany, Poland, Singapore, Sweden, Switzerland and United Kingdom.
Lot / Code Info
Model: 866120, Lot numbers: US33600004, US33600005, US33600006, US33600007, US33600008, US33600009, US33600010, US33600011, US33600012, US33600013, US33600014, US33600015, US33600016, US33600017, US33600018, US33600019, US33600020, US33600022, US33600023, US33600024, US33600025, US33600026, US33600027, US33600028.
Root Cause
Process control
Action Taken
Philips Medical Systems sent an Urgent - Medical Device Correction letter dated July 9, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Our records indicate that you have an affected device. The following page provides additional instructions and actions that will be taken to address this problem. If you need any further information or support concerning this issue, please contact your local Philips representative: 877-468-4861 option 1, then option 2.