BEUDAMED
    FDA Recall Terminated

    Maquet Getinge Group Operating Table System Magnus Carbon-Fibre Table Top Version 1180.16 The carbon-fibre MAGNUS table top (1180-16XX) serves to support and position patients for surgical procedures (e.g. cardiovascular surgery) and interventional examination immediately before, during and after the surgical phase. The table top is radiotranslucent and enables intraoperative use of X-ray equipment.

    Recall: Z-2108-2012 · Initiated April 13, 2012

    Recall

    Recall Number
    Z-2108-2012
    Event Number
    62590
    Firm
    Maquet Medical Systems, Usa
    FEI Number
    3001451475
    Product Code
    FQO
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 13, 2012
    Posted
    July 30, 2012
    Terminated
    September 4, 2013
    Address
    45 Barbour Pond Dr, Wayne, NJ, 07470-2094

    Description

    Maquet Getinge Group Operating Table System Magnus Carbon-Fibre Table Top Version 1180.16 The carbon-fibre MAGNUS table top (1180-16XX) serves to support and position patients for surgical procedures (e.g. cardiovascular surgery) and interventional examination immediately before, during and after the surgical phase. The table top is radiotranslucent and enables intraoperative use of X-ray equipment.

    Reason

    As a result of a small number of customer complaints, MAQUET conducted an investigation and identified a potential problem with specific MAGNUS Carbon-Fibre Table Tops manufactured between February 23, 2010 and February 28, 2012 and distributed between November 11, 2010 and April 6, 2012. There is a potential issue with the motor brakes for the longitudinal shift drive, and the tilt drive.

    Action

    MAQUET GETINGE Group sent An "Urgent Device Field Correction" notification, dated 13 April 2012 via Federal Express to all affected customers. An acknowledgement form is included with the customer letter which can be mailed or faxed back to Maquet Quality by the notified customers. If the completed Acknowledgement form is not received within 15 days, up to three follow ups will be made and documented via telephone call to each customer. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use and notify their MAQUET Service Representative immediately. The MAQUET Service Representative will contact customers to make arrangements to replace both te logitudinal shift and tilt drives of their table top(s). For questions customers should call 888-627-8383, press option 2, followed by option 1. For questions regarding this recall call 201-995-8968.

    Distribution

    Worldwide Distribution - USA (nationwide) and the countries of United Arab Emirates, Austria, Australia, Belgium, Brazil, Canada, Switzerland, China, Germany, Denmark, Spain, France, Hong Kong, Ireland, Israel, India, Italy, Japan, South Korea, Netherlands, Poland, Russia, Saudi Arabia, Sweden, Singapore, and Thailand.

    Quantity

    164 Units located in 27 Countries