Recall Z-0292-2016 ยท DRX Electrode, Electrocardiograph
Leonhard Lang Medizintechnik GmbH
ECG Electrodes: 50007 Stablebase SBW55 50675 Stablebase SBW55-15 58051 Skintact W-60 50547 Stablebase SBT60 Only OUS: 50476 Skintact W-60HP E3 I 58046 Skintact T-60 I Patz K920 58688 Dahlhausen 1900000440 59629 Cardionetics CN-15-W60 58789 Lessa 99.832.02 58872 EF Medica FS 50 LG 50359Ultragel FS50LG
| Date | Nov 18, 2015 (initiated Nov 2, 2015) |
| Status | Terminated |
| Reason | There is a risk ECG electrodes of specific lots fail to transmit signals. There is a risk that the affected electrodes will transmit a poor signal or no signal at all before reaching the indicated expiration date. |
| Root cause | Nonconforming Material/Component |
| Action | Leonhard Lang emailed an "Important Safety Notice" letter dated November 2, 2015, to all affected customers on November 2, 2015.. The letter identified the product the problem and the action needed to be taken by the customer. The letter provided information on: 1. Description of the defect; 2. Actions and time frame of the recall; 3. Replacement of the electrodes & contact information. For questions call : +43 512 33425-39. |
| Quantity | 16,410,800 (10,226,600 US:, 184,200 OUS) |
| Distribution | Worldwide Distribution - US Distribution to the state of : FL., and to the countries of : Australia, Austria, Croatia, Czech Republic, Estonia, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Japan, Malta, Norway, Poland, Portugal, Romania, Serbia, Spain, Switzerland, Thailand, Turk |
| 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 |