Events

Recall of Spacelabs Healthcare CardioExpress SL6 ECG cable

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Del Mar Reynolds Medical, Ltd..

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
    60803
  • Event Risk Class
    Class 2
  • Event Number
    Z-0743-2012
  • Event Initiated Date
    2010-09-10
  • Event Date Posted
    2012-01-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-01-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106510
  • 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
    Electrocardiograph - Product Code DPS
  • Reason
    Cardioexpress sl6 ecg cable provided with the electrocardiograph is mislabeled. the left arm (la) is mislabeled as right leg (rl). the left leg (ll) is mislabeled as left arm (la). the right leg (rl) is mislabeled as left leg (ll).
  • Action
    Spacelabs Healthcare sent an "URGENT-MEDICAL DEVICE CORRECTION" letter dated September 24, 2010 to one affected customer in Massachusetts. The letter described the product, problem, and actions to be taken by the customers. Customers were instructed to review previous diagnoses made from this electrocardiograph to mitigate any inappropriate recordings or treatment made, and dispose of the mislabeled ECG cable to prevent its use. Spacelabs replaced the affected ECG cable with the new ECG cable. If you have any questions about this corrective action program, please contact Spacelabs Healthcare at 1-800-522-7025 and select 2 for Technical Support.

Device

Spacelabs Healthcare CardioExpress SL6 ECG cable
  • Model / Serial
    Serial numbers:  98400-SL6-AHA1030508, 98400-SL6-AHA1030509, 98400-SL6-AHA1030510, 98400-SL6-AHA1030511, 98400-SL6-AHA1030512, 98400-SL6-AHA1030513, 98400-SL6-AHA1030514, 98400-SL6-AHA1030515, 98400-SL6-AHA1030516, 98400-SL6-AHA1030517, 98400-SL6-AHA1030518, 98400-SL6-AHA1030519, 98400-SL6-AHA1030520, 98400-SL6-AHA1030521, 98400-SL6-AHA1030522.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution.
  • Product Description
    Affected device is Model 98400-SL6-AHA, CardioExpress Electrocardiograph. The ECG cable part number is 01.57.471017. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. || The intended use of electrocardiograph is to acquire ECG signals from adult and pediatric patients through body surface with ECG electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. However, the interpreted ECG with measurements and interpretive statements is only intended to be used on adult patients and is offered to clinicians on an advisory basis only.
  • Manufacturer
    Del Mar Reynolds Medical, Ltd.

Manufacturer

Del Mar Reynolds Medical, Ltd.
  • Manufacturer Address
    Del Mar Reynolds Medical, Ltd., 1-2 Harforde Ct., Foxholes, Business Park, Hertford United Kingdom
  • Manufacturer Parent Company (2017)
    OSI Systems Inc
  • Source
    USFDA