Events

Recall of Device Recall Skintact ECG Electrode FS50, Stable Base ECG Electrode SBT60

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Leonhard Lang Medizintechnik GmbH.

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
    70704
  • Event Risk Class
    Class 2
  • Event Number
    Z-1350-2015
  • Event Initiated Date
    2015-02-24
  • Event Date Posted
    2015-03-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-07-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134522
  • 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
    Electrode, electrocardiograph - Product Code DRX
  • Reason
    The electrodes may fail to transmit signals.
  • Action
    Consignees were sent via e-mail a Leonhard Lang "Important Safety Notice" letter, dated 24 February 2015. The letter provided the Product trade name, Affected lot numbers, Required Action, Target audience, Details of the affected product which included Description of the problem and Measures to be taken by the user. The letter advised consignees to quarantine the affected product, and to complete and return the acknowledgment form to Leonhard Lang. For questions contact either Sophie Hurmann, Sales Department (tel: +43 512 33425 - 45, fax: +43 512 39 22 10, e-mail: sophia.hurmann@leonhardlang.at) , Stefan Rudig, Quality Department ,(tel: +43 512 33425 -15, fax: +43 512 39 22 10 e-mail: stefan.rudig@leonhardlang.at), or Bernhard Ladner,Qualitats Manager (tel: +43 512 33425- 39, fax: +43 512 39 22 10, e-mail: bernhard.ladner@leonhardlang.at) .

Device

Device Recall Skintact ECG Electrode FS50, Stable Base ECG Electrode SBT60
  • Model / Serial
    FS-50 Lot: 40120-0093 FS-50 Lot: 40117-0091 FS-50 Lot: 40116-0099 T -60 Lot: 40116-0323 T-60 Lot: 40120-0326 T -60 Lot: 40120-0154 T -60 Lot: 40117-0325 T -60 Lot: 40117-0153 T -60 Lot: 40116-0152 T -60 Lot: 40115-0322
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed to FL.
  • Product Description
    Skintact ECG Electrode FS-50, Catalog no. 58028 , & Stable Base ECG Electrode SBT-60, Catalog no. 50547. || To acquire and transmit the electrical signal at the body surface to a processor that produces an electrocardiogram (ECG) or vectorcardiogram.
  • Manufacturer
    Leonhard Lang Medizintechnik GmbH

Manufacturer

Leonhard Lang Medizintechnik GmbH
  • Manufacturer Address
    Leonhard Lang Medizintechnik GmbH, Archenweg 56, Innsbruck Austria
  • Source
    USFDA