Recall Z-1156-2009 ยท DQK Computer, Diagnostic, Programmable
St. Jude Medical
NurseMate with Physio Module; Remote Review, Monitoring and Charting Station; USA EPMedSystems, Inc. Cooper Run Executive Park, 575 Route 73 North, Unit D, West Berlin, NJ 08090. Outer box labeled as Smiths Medical. The NurseMate Remote Review Station is an integrated review station for the EP WorkMate Computer recording system that allows a separate user to review and edit patient study date sto
| Date | Apr 10, 2009 (initiated Feb 13, 2009) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 4 units |
| Distribution | Nationwide Distribution -- CA, NV, and FL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070706 | EP-WORKMATE Ep Medsystems, Apr 11, 2007 |