Leonhard Lang Gmbh
ARCHENWEG 56, INNSBRUCK Tirol, AT
Registered product codes
12 product codes
Recent MDR events
471 on file
- GS corPatchJul 29, 2026Death8020045-2026-00024
- GS CORPATCHJul 22, 2026Malfunction8020045-2026-00022
- ERBEJul 22, 2026Injury8020045-2026-00023
- SKINTACTJul 16, 2026Injury8020045-2026-00021
- SKINTACTJul 7, 2026Malfunction8020045-2026-00020
- SKINTACTJul 1, 2026Injury8020045-2026-00019
- GS CORPATCHJun 25, 2026Malfunction8020045-2026-00018
- SKINTACTJun 22, 2026Injury8020045-2026-00016
- SKINTACTJun 22, 2026Malfunction8020045-2026-00017
- MEGADYNEMay 19, 2026Injury8020045-2026-00015
Recalls
3 on file
- TerminatedDec 19, 2014
The firm discovered that during the use of these defibrillation electrodes a possibility for arcing and a resulting malfunction exists. This could lead to a situation, in which a patient who is in a life threatening situation requiring a defibrillation can receive such therapy only with a delay or not at all.
View FDA record ↗ - TerminatedSep 24, 2009
A potential risk was identified associated with the connectors of the defibrillation electrodes DF20. It was found that some of the connectors do not slip easily into the sockets of the defibrillator or an extension cord of the defibrillator. In such cases increased force or some wiggling is required to insert the connector fully. A potential risk for patients exist, if (a) such a connector (b)
View FDA record ↗ - TerminatedSep 24, 2009
A potential risk was identified associated with the connectors of the defibrillation electrodes DF20. It was found that some of the connectors do not slip easily into the sockets of the defibrillator or an extension cord of the defibrillator. In such cases increased force or some wiggling is required to insert the connector fully. A potential risk for patients exist, if (a) such a connector (b)
View FDA record ↗
Compliance history
Matched by FEI 6736.
FDA inspections
0 on file
No inspections on file for this FEI number.
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
1 on file
Top refusal reasons
Compare to industry ↗- Division of Southwest Imports (DSWI)Jul 8, 2026
84GXY \ ELECTRODE, CUTANEOUS