Recall Z-0292-2016— Leonhard Lang Medizintechnik GmbH
Class II · Terminated
Class II FDA medical device recall by Leonhard Lang Medizintechnik GmbH, initiated 2015-11-02, terminated 2017-11-21. It names one FDA 510(k) clearance: K024247. 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. 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..
- Recalling firm
- Leonhard Lang Medizintechnik GmbH
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-11-02
- Terminated
- 2017-11-21
- Firm location
- Innsbruck, N/A, Austria
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.