Z-2079-2012 Class II Terminated
FDA device recall Z-2079-2012 was initiated by Getinge USA Inc on May 25, 2012 and is designated Class II. Reason for recall: 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 recall status is terminated (terminated May 18, 2016). Affected quantity: 8 washers.
Recall Details
- Product Type
- Devices
- Report Date
- August 1, 2012
- Initiation Date
- May 25, 2012
- Termination Date
- May 18, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8 washers
Product Description
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
Reason for Recall
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.
Distribution Pattern
Worldwide Distribution - USA including Maryland, Indiana, New Mexico, Massachuesetts, Texas, Kansas and the country of Canada
Code Information
Serial numbers: W50024258; W50024259; W50026573; W50025790; W50017381; W50020296; W50028138; W50020952