Recall StatusTerminated
Date Initiated2020-02-10
Date Terminated2023-09-13
Product Quantity146 US
Reason for Recall
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
Firm 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 Pattern
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
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.