Recall Z-0069-2015
Invivo Corporation · initiated September 5, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Philips Expression MR200 MRI Patient Monitoring System
Codes / lots: 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.
Reason for recall
Failure to produce the Non-Invasive Blood Pressure (NIBP) Measurement.
FDA-determined 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.
Details
- Recall number
- Z-0069-2015
- Initiated
- September 5, 2014
- Posted by FDA
- October 15, 2014
- Terminated
- October 12, 2017
- Product code
- MWI – Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- Quantity
- 24 units.
- 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.
- Recalling firm
- Invivo Corporation, Orlando, FL