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
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
production error