Leonhard Lang Recalls ECG Electrodes Due to Signal Transmission Failure
Leonhard Lang Medizintechnik GmbH is recalling specific lots of ECG electrodes because they may fail to transmit signals or transmit poor signals before expiration.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (diagnostic failure) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Leonhard Lang Medizintechnik GmbH is recalling specific lots of ECG electrodes, including models such as Stablebase SBW55, Skintact W-60, and Stablebase SBT60. The recall involves approximately 16.4 million units distributed worldwide, including in the United States and various international markets.
The recall is being issued because there is a risk that the affected electrodes will fail to transmit signals. Specifically, the electrodes may transmit a poor signal or no signal at all before reaching their indicated expiration date. This failure could impact the accuracy of electrocardiogram readings.
Consumers and healthcare facilities should check their inventory for the specific lot numbers listed in the official FDA recall notice Z-0292-2016. If the product matches the recalled lots, it should be removed from use and returned to the manufacturer or distributor for credit or replacement.
The recalled product
- 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 5
- Manufacturer
- Leonhard Lang Medizintechnik GmbH
- Category
- Medical Device — ECG Electrodes
Distribution
Distributed in 1 state:
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