ECG Electrodes: 50007 Stablebase SBW55 50675 Stablebase SBW55-15 58051 Skintact W-60 50547 Stablebase SBT60 Only OUS: 50
FDA device recall Z-0292-2016 · posted 2015-11-18 · Terminated
Recall details
- Recalling firm
- Leonhard Lang Medizintechnik GmbH
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- DRX
- Quantity affected
- 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
- Date initiated
- 2015-11-02
- Date posted
- 2015-11-18
- Date terminated
- 2017-11-21
- Location
- Innsbruck, Austria
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SKINTACT ECG ELECTRODES WITH KL 02 LIQUID GEL (K024247) | Leonhard Lang GmbH | 2003-01-16 |