Events

Recall of Tru-Link DIN unshielded ECG cable, 5-lead

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

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
    33458
  • Event Risk Class
    Class 3
  • Event Number
    Z-0063-06
  • Event Initiated Date
    2005-09-16
  • Event Date Posted
    2005-11-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-02-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41911
  • 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
    Detector And Alarm, Arrhythmia - Product Code DSI
  • Reason
    Ecg 5-lead cable miswired - a physician could interpret the incorrect polarities as a conduction defect.
  • Action
    On 9/16/05 the firm sent a letter to their customers advising of the problem. The customer was requested to check the code on their cables, and if the suspect code, discard the cable. The customer was provided a response sheet to indicate they received the notification and to request new cables.

Device

Tru-Link DIN unshielded ECG cable, 5-lead
  • Model / Serial
    Lot codes: 31942, 34956, 35209, 35296, 35747, 36239, 36555 Part number: 012-0123-01
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Cables were distributed to 9 US hospitals/medical centers and 30 international customers.
  • Product Description
    Tru-Link DIN unshielded ECG cable, 5-lead
  • Manufacturer
    Spacelabs Medical Incorporated

Manufacturer

Spacelabs Medical Incorporated
  • Manufacturer Address
    Spacelabs Medical Incorporated, 5150 220th Ave Se, Issaquah WA 98029-6834
  • Source
    USFDA