Z-1350-2015 Class II Terminated

Recalled by Leonhard Lang Medizintechnik GmbH — Innsbruck, N/A

Recall Details

Product Type
Devices
Report Date
April 8, 2015
Initiation Date
February 24, 2015
Termination Date
July 26, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
364,800

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.

Distribution Pattern

Distributed to FL.

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