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U.S. Department of Health and Human Services

Class 2 Device Recall EPWORKMATE

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 Class 2 Recall
EPWORKMATE
see related information
Date Posted April 10, 2009
Recall Status1 Terminated on May 04, 2009
Recall Number Z-1156-2009
Recall Event ID 51195
Premarket Notification
510(K) Number
K070706 
Product Classification Computer, Diagnostic, Programmable - Product Code DQK
Product 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 stored on the SP Work Mate System and monitor patient data from the EP WorkMate during a Patient study.
Code Information Smith Medical Part Number: 87-1785-0000; Serial Numbers: AM08080015, AM08080016, AM08080017, AM08080018, AM08080019, AM08100004, AM08100005, AM08100006, AM08100007 and AM08100008.
Recalling Firm/
Manufacturer
St. Jude Medical
575 Route 73 North, Bldg D
Cooper Run Executive Park
West Berlin, New Jersey 08091
For Additional Information Contact Angela Craig
856-753-8533
Manufacturer 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.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): 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 in Commerce 4 units
Distribution Nationwide Distribution -- CA, NV, and FL.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DQK and Original Applicant = EP MEDSYSTEMS
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