Recall Z-3109-2017— Leonhard Lang Medizintechnik GmbH
Class I · Terminated
Class I FDA medical device recall by Leonhard Lang Medizintechnik GmbH, initiated 2017-08-08, terminated 2020-06-09. It names one FDA 510(k) clearance: K142803. Product: Skintact Electrode for Defibrillation, Pacing, Monitoring, Cardioversion. Product Usage: Multifunction electrode for external defibrillation, pacing, cardioversion, and monitoring. The device is non-sterile and for single use only. Used with automated external defibrillators. Reason: Certain lots of the defibrillation electrodes model DF59N and DF59NC may have a delay in connecting or not connect at all with the defibrillator ZOLL AED PLUS. This may cause a situation in which a patient, who is in a life threatening condition and requires a defibrillation shock, cannot be treated in good time..
- Recalling firm
- Leonhard Lang Medizintechnik GmbH
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2017-08-08
- Terminated
- 2020-06-09
- 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
Skintact Electrode for Defibrillation, Pacing, Monitoring, Cardioversion. Product Usage: Multifunction electrode for external defibrillation, pacing, cardioversion, and monitoring. The device is non-sterile and for single use only. Used with automated external defibrillators
Reason for recall
Certain lots of the defibrillation electrodes model DF59N and DF59NC may have a delay in connecting or not connect at all with the defibrillator ZOLL AED PLUS. This may cause a situation in which a patient, who is in a life threatening condition and requires a defibrillation shock, cannot be treated in good time.
Data sourced from openFDA. This site is unofficial and independent of the FDA.