Reported Apr 8, 2015 · Terminated

Skintact ECG Electrode FS-50, Catalog no. 58028 , & Stable Base ECG Electrode SBT-60, Catalog no. 50547. To acquire and…

Leonhard Lang Medizintechnik GmbH

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Leonhard Lang Medizintechnik GmbH · Archenweg 56 · Innsbruck, N/A · N/A

Is this the product you have?

  • 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.
Lot codes and dates
  • FS-50 Lot40120-0093
  • FS-50 Lot40117-0091
  • FS-50 Lot40116-0099
  • T -60 Lot40116-0323
  • T-60 Lot40120-0326
  • T -60 Lot40120-0154
  • T -60 Lot40117-0325
  • T -60 Lot40117-0153
  • T -60 Lot40116-0152
  • T -60 Lot40115-0322
Amount recalled
364,800

Where it was sold

Why it was recalled

The electrodes may fail to transmit signals.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 26, 2017 · Data as of Sep 19, 6:14 PM UTC

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