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Terminated

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.

FDA Recall Z-1350-2015 · Posted 2015-03-28

Recall StatusTerminated
Product CodeDRX
Date Initiated2015-02-24
Date Terminated2017-07-26
Product Quantity364,800

Reason for Recall

The electrodes may fail to transmit signals.

Firm 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]) .

Root Cause

Nonconforming Material/Component

Distribution Pattern

Distributed to FL.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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