Recall Z-1350-2015 ยท DRX Electrode, Electrocardiograph
Leonhard Lang Medizintechnik GmbH
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.
| Date | Mar 28, 2015 (initiated Feb 24, 2015) |
| Status | Terminated |
| Reason | The electrodes may fail to transmit signals. |
| 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: sophia.hurmann@leonh |
| Quantity | 364,800 |
| Distribution | Distributed to FL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K024247 | SKINTACT ECG ELECTRODES WITH KL 02 LIQUID GEL Leonhard Lang GmbH, Jan 16, 2003 |