Events

Recall of Device Recall EPWORKMATE

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by St. Jude Medical.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    51195
  • Event Risk Class
    Class 2
  • Event Number
    Z-1156-2009
  • Event Initiated Date
    2009-02-13
  • Event Date Posted
    2009-04-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-05-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=79130
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Computer, diagnostic, programmable - Product Code DQK
  • 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.
  • 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.

Device

Device Recall EPWORKMATE
  • Model / Serial
    Smith Medical Part Number: 87-1785-0000; Serial Numbers: AM08080015, AM08080016, AM08080017, AM08080018, AM08080019, AM08100004, AM08100005, AM08100006, AM08100007 and AM08100008.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- CA, NV, and FL.
  • Product Description
    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.
  • Manufacturer
    St. Jude Medical

Manufacturer

St. Jude Medical
  • Manufacturer Address
    St. Jude Medical, 575 Route 73 North, Bldg D, Cooper Run Executive Park, West Berlin NJ 08091
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA