Recall StatusTerminated
Date Initiated2019-05-20
Date Terminated2023-12-15
Product Quantity4 units
Reason for Recall
Possibility that inlet pump hose of the Washer Disinfector Getinge 86-Series (S-8666, S-8668) might collapse during use result in low water pressure within the circulation system and, in the worst case scenario, can result in the contents of the Washer Disinfector not being cleaned properly after finished process.
Firm Action
Getinge issued a An Urgent Medical Device Correction to U.S. consignees on 5/20/19 via FedEx 2 day Delivery with Signature Proof of Delivery (SPOD). Letter provides identification of the issue, health risk and action to take: examine your inventory immediately, Until the required correction has been completed, take the following precautions detailed in the User Manual: Do not operate the machine unattended. Always inspect the processed goods after a wash cycle.
Contact a Getinge Service person if either of these are noticed:
o If the washer starts to sound different than usual during a wash cycle, abort the process and call your service person.o Goods are not cleaned after the process is finished. Getinge Service person will contact the person you listed on the Customer Response Form to schedule service for an update of your device, free of charge. You can also arrange a visit by a Getingetrained or authorized service technician by calling Getinge Customer Support at 18009509912 (select option 1). Customer Service hours: 8:00 AM to 5:00 PM (EST) Monday to
Friday
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution - US Nationwide GA, IL, IN, MI, NC, OR, PA, VA
Foreign:
Australia, Canada, China, France, Germany, India, Japan, Korea, Netherlands, Saudi Arabia, South Africa, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, Ukraine
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.