Recall Z-1350-2015— Leonhard Lang Medizintechnik GmbH

Name: FDA recall Z-1350-2015
Creator: U.S. Food and Drug Administration
Published: 2015-02-24

Class II · Terminated

Class II FDA medical device recall by Leonhard Lang Medizintechnik GmbH, initiated 2015-02-24, terminated 2017-07-26. It names one FDA 510(k) clearance: K024247. 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.. Reason: The electrodes may fail to transmit signals..

Recalling firm: Leonhard Lang Medizintechnik GmbH
Classification: Class II
Status: Terminated
Initiated: 2015-02-24
Terminated: 2017-07-26
Firm location: Innsbruck, N/A, Austria

510(k) clearances named in this recall

1 on FDA's record

K024247 — SKINTACT ECG ELECTRODES WITH KL 02 LIQUID GELLeonhard Lang GmbH·cleared 2003-01-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

The electrodes may fail to transmit signals.

Data sourced from openFDA. This site is unofficial and independent of the FDA.