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U.S. Department of Health and Human Services

Class 2 Device Recall Skintact ECG Electrode FS50, Stable Base ECG Electrode SBT60

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  Class 2 Device Recall Skintact ECG Electrode FS50, Stable Base ECG Electrode SBT60 see related information
Date Initiated by Firm February 24, 2015
Date Posted March 28, 2015
Recall Status1 Terminated 3 on July 26, 2017
Recall Number Z-1350-2015
Recall Event ID 70704
510(K)Number K024247  
Product Classification Electrode, electrocardiograph - Product Code DRX
Product 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.


Code Information 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
Recalling Firm/
Manufacturer		 Leonhard Lang Medizintechnik GmbH
Archenweg 56
Innsbruck Austria
Manufacturer Reason
for Recall		 The electrodes may fail to transmit signals.
FDA Determined
Cause 2		 Nonconforming Material/Component
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) .
Quantity in Commerce 364,800
Distribution Distributed to FL.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DRX and Original Applicant = LEONHARD LANG GMBH
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