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.
Recall
- Recall Number
- Z-1350-2015
- Event Number
- 70704
- Firm
- Leonhard Lang Medizintechnik GmbH Archenweg 56 Innsbruck Austria
- FEI Number
- 6736
- Product Code
- DRX
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- February 24, 2015
- Posted
- March 28, 2015
- Terminated
- July 26, 2017
Description
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.
The electrodes may fail to transmit signals.
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]) .
Distributed to FL.
364,800