BEUDAMED
    FDA Recall Terminated

    Leica Microsystems products labeled as the following: Leica M320 Microscope Systems with Article Numbers 10448419, 10448420, 10448485, 10448486 Product Usage: Intended use of this device is an optical instrument for magnifying and illuminating specimens. It can be applied for observation and documentation and for human and veterinary medical treatment. Not for use in Eye Operations.

    Recall: Z-2555-2018 · Initiated June 4, 2018

    Recall

    Recall Number
    Z-2555-2018
    Event Number
    80229
    Firm
    Leica Microsystems, Inc.
    FEI Number
    3000210133
    Product Code
    EPT
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    June 4, 2018
    Terminated
    March 25, 2021
    Address
    1700 Leider Ln, Buffalo Grove, IL, 60089-6622

    Description

    Leica Microsystems products labeled as the following: Leica M320 Microscope Systems with Article Numbers 10448419, 10448420, 10448485, 10448486 Product Usage: Intended use of this device is an optical instrument for magnifying and illuminating specimens. It can be applied for observation and documentation and for human and veterinary medical treatment. Not for use in Eye Operations.

    Reason

    Possible failure of screws which hold the gas spring fixation bracket in place. Due to this failure, the gas spring, which is fixed to the upper part of the parallelogram, cannot hold up the weight of the optics carrier.

    Action

    Leica Microsystems notified customers on about 06/04/2018 via URGENT FIELD SAFETY NOTICE letter. The letter informed customers that they would be contacted by a Leica Microsystems representative to arrange for the field update in the next 12 months. Customers were instructed that they could continue to use the system pending the update if they ensure a functional check is performed prior to surgery and follow user manual directions. If any anomalies are noticed prior to the correction, customers should contact their Leica representative. Customers were also instructed to provide the notification to all appropriate personnel , notify customers if the unit was transferred, and complete and return the Medical Device Correction Form. A follow-up recall notification was sent to customers on or about 06/07/2018. The follow up letter discusses the functional check prior to use and provides additional compliant information.

    Distribution

    Worldwide Distribution US Nationwide in the states of : CA, CO, CT, FL, HI, ID, IL, KS, KY, LA, MD, MI, MN, MO, NC, NJ, NY, OH, PA, SD, TN, TX. International Distribution: Canada, AUSTRALIA, BELGIUM, Bolivia, BRAZIL, BULGARIA, CHILE, CHINA, DENMARK, EGYPT, EL SALVADOR, FINLAND, FRANCE, GERMANY, HONGKONG, HUNGARY, INDIA, ISRAEL, ITALY, JAPAN, KUWAIT, MALAYSIA, PHILIPPINES, POLAND, PORTUGAL, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, TAIWAN,THAILAND, TURKEY, UK

    Quantity

    8,564 Total Units