Philips Expression MR200 MRI Patient Monitoring System Model 866120
FDA device recall Z-0001-2015 · posted 2014-10-01 · Terminated
Recall details
- Recalling firm
- Invivo Corporation
- Reason for recall
- During production, excess metal (aluminum) debris was found stuck to the cling plastic that covers the device's pole assembly. The metallic debris could affect system performance due to the potential for a failure to power up or loss of power. This could result in the loss of monitoring and a delay in diagnosis of the patient.
- Action taken
- The firm, Philips Healthcare, sent an "URGENT- Medical Device Recall" letter dated June 17, 2014, to its customers informing them of the product, problem and actions taken. The firm informed the customers that there are no additional actions required on their part. The Philips/Invivo Account Manager will contact them in order to arrange for replacement of the device. If you need any further information or support concerning this issue, contact your local Philips/Invivo representative: 877-468-4861 option 1, then option 2.
- Root cause
- Material/Component Contamination
- Status
- Terminated
- Product code
- MWI
- Quantity affected
- 10 units
- Distribution
- Worldwide Distribution: US distribution in state of: CA and countries of: Poland, Singapore, and Sweden.
- Date initiated
- 2014-09-08
- Date posted
- 2014-10-01
- Date terminated
- 2017-01-09
- 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 |