Leonhard Lang ECG Electrodes Recalled for Signal Transmission Failure
Leonhard Lang is recalling specific lots of Skintact and Stable Base ECG electrodes because they may fail to transmit signals.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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. The hazard involves a functional failure of a medical device that could lead to diagnostic errors, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Leonhard Lang Medizintechnik GmbH is recalling 364,800 units of Skintact ECG Electrode FS-50 and Stable Base ECG Electrode SBT-60. The recall involves specific lots of these medical devices, which are used to acquire and transmit electrical signals from the body surface to produce an electrocardiogram (ECG) or vectorcardiogram.
The recall was initiated because the electrodes may fail to transmit signals. This defect could prevent the accurate acquisition of electrical signals necessary for diagnostic testing. The affected products were distributed to Florida.
Healthcare facilities and consumers who have these specific lots of ECG electrodes should stop using them and contact the manufacturer for instructions on return or replacement. The recall is classified as Class II by the FDA, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- 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.
- Manufacturer
- Leonhard Lang Medizintechnik GmbH
- Category
- Medical Device — ECG Electrodes
- Affected units
- 364,800
Distribution
Distributed in 1 state:
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