Z-1350-2015Class II

Skintact ECG Electrode FS-50, Catalog no. 58028 , & Stable Base ECG Electrode SBT-60, Catalog no. 50547. To...

Name: Z-1350-2015 Skintact ECG Electrode FS-50, Catalog no. 58028 , & Stable Base ECG Electrode SBT-60, Catalog no. 50547. To...
Creator: Leonhard Lang Medizintechnik GmbH
Published: 2015-02-24
License: https://open.fda.gov/license/

Leonhard Lang GmbH / initiated 2015-02-24 / Terminated / root cause: manufacturing process

FDA source

Leonhard Lang Medizintechnik GmbH began a recall of 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... on 2015-02-24. FDA classified it as Class II and gives the reason as "The electrodes may fail to transmit signals". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1350-2015
Classification: Class II
Status: Terminated
Initiated: 2015-02-24
Posted: 2015-03-28
Terminated: 2017-07-26
Recalling firm: Leonhard Lang GmbH
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.
Product code: DRX Electrode, Electrocardiograph
Reason for recall: The electrodes may fail to transmit signals.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Consignees were sent via e-mail a Leonhard Lang "Important Safety Notice" letter, dated 24 February 2015. The letter provided the Product trade name, Affected lot numbers, Required Action, Target audience, Details of the affected product which included Description of the problem and Measures to be taken by the user. The letter advised consignees to quarantine the affected product, and to complete and return the acknowledgment form to Leonhard Lang. For questions contact either Sophie Hurmann, Sales Department (tel: +43 512 33425 - 45, fax: +43 512 39 22 10, e-mail: [email protected]) , Stefan Rudig, Quality Department ,(tel: +43 512 33425 -15, fax: +43 512 39 22 10 e-mail: [email protected]), or Bernhard Ladner,Qualitats Manager (tel: +43 512 33425- 39, fax: +43 512 39 22 10, e-mail: [email protected]) .
Quantity in commerce: 364,800
Distribution: Distributed to FL.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1350-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1350-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-08	2015-03-27

Product code DRX

K024247Class IISkintact ECG Electrodes with Kl 02 Liquid GelLeonhard Lang GmbH / cleared 2003-01-16

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)