FDA Device recall Z-0292-2016
ECG Electrodes: 50007 Stablebase SBW55 50675 Stablebase SBW55-15 58051 Skintact W-60 50547 Stablebase SBT60 Only OUS: 50476 Skintac…
- FDA Device
- Class II
- terminated
- Published 2015-11-25
On 2015-11-25 the FDA classified a Class II recall of ECG Electrodes: 50007 Stablebase SBW55 50675 Stablebase SBW55-15 58051 Skintact W-60 50547 Stablebase SBT60 Only OUS: 50476 Skintac… by Leonhard Lang Medizintechnik, citing 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 reach….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0292-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-11-02 |
| Published | 2015-11-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Leonhard Lang Medizintechnik |
| Distribution | FL |
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.
Identifiers
| code_info | List of models and lot numbers - USA Artikel No. Brand / Model Lot Nos. Skintact W-60 (30/1200) 58051 Skintact W-60…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0292-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.