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
FDA Recall Z-0292-2016 · Posted 2015-11-18
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Recalling FirmLeonhard Lang Medizintechnik GmbH
Recall StatusTerminated
Product CodeDRX
Date Initiated2015-11-02
Date Terminated2017-11-21
Product Quantity16,410,800 (10,226,600 US:, 184,200 OUS)
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.
Firm Action
Leonhard Lang emailed an "Important Safety Notice" letter dated November 2, 2015, to all affected customers on November 2, 2015.. The letter identified the product the problem and the action needed to be taken by the customer.
The letter provided information on:
1. Description of the defect;
2. Actions and time frame of the recall;
3. Replacement of the electrodes & contact information.
For questions call : +43 512 33425-39.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution - US Distribution to the state of : FL., and to the countries of : Australia, Austria, Croatia, Czech Republic, Estonia, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Japan, Malta, Norway, Poland, Portugal, Romania, Serbia, Spain, Switzerland, Thailand, Turkey and United Arab Emirates.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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