Philips Expression MR200 MRI Patient Monitoring System
FDA device recall Z-0069-2015 · posted 2014-10-15 · Terminated
Recall details
- Recalling firm
- Invivo Corporation
- Reason for recall
- Failure to produce the Non-Invasive Blood Pressure (NIBP) Measurement.
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- MWI
- Quantity affected
- 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.
- Date initiated
- 2014-09-05
- Date posted
- 2014-10-15
- Date terminated
- 2017-10-12
- Location
- Orlando, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EXPRESSION MR200 MRI PATIENT MONITORING SYSTEM, EXPRESSION IP5 INFORMATION PORTAL (K131382) | Invivo Corporation | 2013-07-15 |