BEUDAMED
    FDA Recall Terminated

    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

    Recall: Z-0292-2016 · Initiated November 2, 2015

    Recall

    Recall Number
    Z-0292-2016
    Event Number
    72575
    Firm
    Leonhard Lang Medizintechnik GmbH Archenweg 56 Innsbruck Austria
    FEI Number
    6736
    Product Code
    DRX
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    November 2, 2015
    Posted
    November 18, 2015
    Terminated
    November 21, 2017

    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

    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.

    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.

    Distribution

    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.

    Quantity

    16,410,800 (10,226,600 US:, 184,200 OUS)