Z-3109-2017Class I

Skintact Electrode for Defibrillation, Pacing, Monitoring, Cardioversion

Name: Z-3109-2017 Skintact Electrode for Defibrillation, Pacing, Monitoring, Cardioversion
Creator: Leonhard Lang Medizintechnik GmbH
Published: 2017-08-08
License: https://open.fda.gov/license/

Leonhard Lang GmbH / initiated 2017-08-08 / Terminated / root cause: design

FDA source

Leonhard Lang Medizintechnik GmbH began a recall of Skintact Electrode for Defibrillation, Pacing, Monitoring, Cardioversion. Product Usage: Multifunction electrode for external defibrillation, pacing... on 2017-08-08. FDA classified it as Class I and gives the reason as "Certain lots of the defibrillation electrodes model DF59N and DF59NC may have a delay in connecting or not connect at all with the defibrillator ZOLL AED PLUS. This may cause a situation in which a patient, who is in a...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-3109-2017
Classification: Class I
Status: Terminated
Initiated: 2017-08-08
Posted: 2017-09-12
Terminated: 2020-06-09
Recalling firm: Leonhard Lang GmbH
Product: Skintact Electrode for Defibrillation, Pacing, Monitoring, Cardioversion. Product Usage: Multifunction electrode for external defibrillation, pacing, cardioversion, and monitoring. The device is non-sterile and for single use only. Used with automated external defibrillators
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: Certain lots of the defibrillation electrodes model DF59N and DF59NC may have a delay in connecting or not connect at all with the defibrillator ZOLL AED PLUS. This may cause a situation in which a patient, who is in a life threatening condition and requires a defibrillation shock, cannot be treated in good time.
Root cause tag: design
FDA root cause: Component design/selection
Action: On approximately 08/08/2017, customers were notified via email of the recall. Instructions included to ensure all users and anyone concerned are aware of the recall, coordinate the replacement of affected product, once replacement electrodes are received document destruction of affected product on-site, and notify customers if the product had been further distributed.
Quantity in commerce: 8,249 units total
Distribution: Worldwide distribution. US distribution in the states of : FL & TX. Austria, China, France, Germany, Greece, Hungary, India, Italy, Panama, Philippines, Poland, Saudi Arabia, Serbia, South Africa, South Korea, Spain, United Arab Emirates, United Kingdom.
Product codes and lots: Model Number DF59N (lot numbers 41219-0778, 50403-0772, 41029-0770), DF59NC (lot numbers 50211-0974, 50402-0974, 40806-0972, 41203-0973, 50116-0975, 50527-0974). Expiration date 09/2017 to 05/31/2018.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3109-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3109-2017	Class I	Terminated	Voluntary: Firm initiated	2017-09-20	2017-09-12

Product code MKJ

K142803Class IIISkintact, various other tradenamesLeonhard Lang GmbH / cleared 2014-12-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)