Skip to content
Recall Observatory FDA recall evidence

Device product

Getinge brand --- large capacity, floor loading jet spray, washers for mechanical washing, intermediate level, thermal disinfection and drying of moisture and temperature stable Hospital case carts, sterilization containers, material handling carts, stands and utensils. --- Model numbers Getinge 9120, 9122, 9125, and 9128

Z-2079-2012

May 25, 2012

Class II

Product summary

Firm
Getinge USA Inc
Event
Event 61974
Status
Terminated
Classification
Class II
Quantity
8 washers
Official record key
device-enforcement:Z-2079-2012

Official wording

Reason: Getinge Disinfection AB is voluntarily correcting Washer Disinfectors, Getinge Electrically Heated 9100-Series manufactured between 2009-05-04 through 09-26-2011. This action is based on a report from the ground fault breaker manufacturer of a production error.

Code information: Serial numbers: W50024258; W50024259; W50026573; W50025790; W50017381; W50020296; W50028138; W50020952

Distribution pattern: Worldwide Distribution - USA including Maryland, Indiana, New Mexico, Massachuesetts, Texas, Kansas and the country of Canada

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    production error