Medical device recalls Moderate risk

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

Recall date
February 24, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1350-2015
FDA classification
Class II
Brand / firm
Leonhard Lang Medizintechnik GmbH
Sold / distributed
Distributed to FL.

Why it was recalled

The electrodes may fail to transmit signals.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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