Recall Z-2079-2012— Getinge USA Inc
Class II · Terminated
Class II FDA medical device recall by Getinge USA Inc, initiated 2012-05-25, terminated 2016-05-18. FDA's recall record names no specific 510(k) clearance for this event. 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. 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..
- Recalling firm
- Getinge USA Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-05-25
- Terminated
- 2016-05-18
- Firm location
- Rochester, NY, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.