FDA Medical Device Recalls (openFDA)
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 stored on the SP Work Mate System and monitor patient data from the EP WorkMate during a Patient study.
- Recall number
- Z-1156-2009
- Recalling firm
- St. Jude Medical
- 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.
- Status
- Terminated
- Initiated
- 2009-02-13
- Posted
- 2009-04-10
- Terminated
- 2009-05-04
- 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.
- Lot, serial or model codes
- Smith Medical Part Number: 87-1785-0000; Serial Numbers: AM08080015, AM08080016, AM08080017, AM08080018, AM08080019, AM08100004, AM08100005, AM08100006, AM08100007 and AM08100008.
- 510(k) numbers
- ["K070706"]
- PMA numbers
- not on file
- Product code
- DQK
- Firm FEI
- 2126673
- Firm city
- West Berlin
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28