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Recall Observatory FDA recall evidence

Device 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.

Z-1350-2015

February 24, 2015

Class II

Product summary

Firm
Leonhard Lang Medizintechnik GmbH
Event
Event 70704
Status
Terminated
Classification
Class II
Quantity
364,800
Official record key
device-enforcement:Z-1350-2015

Official wording

Reason: The electrodes may fail to transmit signals.

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

Distribution pattern: Distributed to FL.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The electrodes may fail to transmit signals.