Recall Z-1350-2015
Leonhard Lang Medizintechnik GmbH · initiated February 24, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / 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
Reason for recall
The electrodes may fail to transmit signals.
FDA-determined cause: Nonconforming Material/Component
Action taken
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: sophia.hurmann@leonhardlang.at) , Stefan Rudig, Quality Department ,(tel: +43 512 33425 -15, fax: +43 512 39 22 10 e-mail: stefan.rudig@leonhardlang.at), or Bernhard Ladner,Qualitats Manager (tel: +43 512 33425- 39, fax: +43 512 39 22 10, e-mail: bernhard.ladner@leonhardlang.at) .
Details
- Recall number
- Z-1350-2015
- Initiated
- February 24, 2015
- Posted by FDA
- March 28, 2015
- Terminated
- July 26, 2017
- Product code
- DRX – Electrode, Electrocardiograph
- Quantity
- 364,800
- Distribution
- Distributed to FL.
- Recalling firm
- Leonhard Lang Medizintechnik GmbH, Innsbruck