BEUDAMED
    FDA Recall Terminated

    Getinge 88-Series-washer disinfectors intended for cleaning, disinfection and drying Model Number: 88-5 Part Number: 88-103; 88-203

    Recall: Z-1475-2020 · Initiated February 10, 2020

    Recall

    Recall Number
    Z-1475-2020
    Event Number
    84884
    Firm
    Maquet Cardiovascular Us Sales, Llc
    FEI Number
    3008355164
    Product Code
    MEC
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 10, 2020
    Posted
    February 18, 2020
    Terminated
    September 13, 2023
    Address
    45 Barbour Pond Dr, Wayne, NJ, 07470-2094

    Description

    Getinge 88-Series-washer disinfectors intended for cleaning, disinfection and drying Model Number: 88-5 Part Number: 88-103; 88-203

    Reason

    Potential leakage that may occur due to ruptured spot welds in the chamber, could generate a situation for the user such as risk for slipping or infection from contaminated water

    Action

    Getinge issued letter dated 2/10/20 Letters via FedEx Priority Overnight Delivery with Signature Proof of Delivery (SPOD).Letter states reason for recall, health risk and action to take: Please examine your inventory immediately to determine if you have any affected Getinge 88-Series Washer Disinfectors (models 88-5) indicated by this notice; Once you have located the affected device, check to see if it is leaking underneath the machine or near the machines foot print. If the machine is leaking, call for Service Technician and plan for service. You can continue to use the machine but we recommend posting a sign for precaution. Units where leakage is observed will be prioritized in order to repair the unit. If your unit is found to be leaking due to this issue, it will be repaired free of charged. You can also arrange a visit by a Getinge trained or authorized service technician by contacting Getinge Customer Technical Support at (888) 9438872 (select option 1, then option 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone). Complete and sign the attached MEDICAL DEVICE RECALL - RESPONSE FORM (page 4) to acknowledge that you have received this notification.

    Distribution

    Nationwide Foreign: Australia, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hong Kong, India, Iraq, Iran, Ireland, Israel, Italy, Japan, Kenya, Lithuania, Netherlands, New Zealand, Norway, Poland, Qatar, Saudi Arabia, Singapore, Slovenia, South Korea, Spain, Sweden, Thailand, Turkey, United Arab Emirates, United Kingdom

    Quantity

    146 US