NurseMate with Physio Module; Remote Review, Monitoring and Charting Station; USA EPMedSystems, Inc. Cooper Run Executiv
FDA device recall Z-1156-2009 · posted 2009-04-10 · Terminated
Recall details
- Recalling firm
- St. Jude Medical
- Reason for recall
- Installation problem: there is a risk that the monitor may not be adequately secured to the stand, resulting in the monitor falling off which may cause injury.
- Action taken
- St. Jude Medical received a recall notice dated January 16, 2009 from its supplier, Smiths Medical PM, Inc. St. Jude Medical prepared and sent their own recall letter dated February 13, 2009 to affected customers. The recall letter described the issue and possible associated risks and provided instructions to customers. A St. Jude Medical representative will contact customers to facilitate replacement of the fasteners. Questions should be directed to your St. Jude Medical sales representative.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- DQK
- Quantity affected
- 4 units
- Distribution
- Nationwide Distribution -- CA, NV, and FL.
- Date initiated
- 2009-02-13
- Date posted
- 2009-04-10
- Date terminated
- 2009-05-04
- Location
- West Berlin, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EP-WORKMATE (K070706) | Ep Medsystems | 2007-04-11 |