Recall Z-0292-2016
Leonhard Lang Medizintechnik GmbH · initiated November 2, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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
Codes / lots: List of models and lot numbers - USA Artikel No. Brand / Model Lot Nos. Skintact W-60 (30/1200) 58051 Skintact W-60 (30/1200) 31113-0159 58051 Skintact W-60 (30/1200) 40304-0324 58051 Skintact W-60 (30/1200) 40325-0153 58051 Skintact W-60 (30/1200) 40326-0154 58051 Skintact W-60 (30/1200) 40416-0326 S&W 620 58205 S&W 620 31121-0155 58205 S&W 620 31122-0156 58205 S&W 620 31125-0159 58205 S&W 620 40730-0324 58205 S&W 620 40901-0328 58205 S&W 620 50723-0326 58205 S&W 620 50827-0329 Stable Base SBW55 50007 Stable Base SBW55 31104-0159 50007 Stable Base SBW55 31107-0321 50007 Stable Base SBW55 31108-0322 50007 Stable Base SBW55 31108-0323 50007 Stable Base SBW55 31111-0324 50007 Stable Base SBW55 31118-0325 50007 Stable Base SBW55 31119-0326 50007 Stable Base SBW55 31120-0327 50007 Stable Base SBW55 31121-0328 50007 Stable Base SBW55 31121-0329 50007 Stable Base SBW55 31122-0321 50007 Stable Base SBW55 31125-0322 50007 Stable Base SBW55 31129-0323 50007 Stable Base SBW55 31202-0324 50007 Stable Base SBW55 31203-0325 50007 Stable Base SBW55 40107-0323 50007 Stable Base SBW55 40107-0324 50007 Stable Base SBW55 40108-0325 50007 Stable Base SBW55 40109-0326 50007 Stable Base SBW55…
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.
FDA-determined cause: Nonconforming Material/Component
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.
Details
- Recall number
- Z-0292-2016
- Initiated
- November 2, 2015
- Posted by FDA
- November 18, 2015
- Terminated
- November 21, 2017
- Product code
- DRX – Electrode, Electrocardiograph
- 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, Turkey and United Arab Emirates.
- Recalling firm
- Leonhard Lang Medizintechnik GmbH, Innsbruck