Z-0018-2014 Class II Terminated
FDA device recall Z-0018-2014 was initiated by Getinge Disinfection on July 30, 2013 and is designated Class II. Reason for recall: Getinge Disinfection AB initiated a voluntary field safety correction for the Getinge 46-Series electrically-heated Washer Disinfectors due to possible overheating. The recall status is terminated (terminated May 11, 2015). Affected quantity: 143 units (142 domestically & 1 unit internationally).
Recall Details
- Product Type
- Devices
- Report Date
- October 23, 2013
- Initiation Date
- July 30, 2013
- Termination Date
- May 11, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 143 units (142 domestically & 1 unit internationally)
Product Description
Getinge 46-Series Medical Washer-Disinfectors, Listing # E208196 Product Usage: The washer disinfector is used in healthcare facilities where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.
Reason for Recall
Getinge Disinfection AB initiated a voluntary field safety correction for the Getinge 46-Series electrically-heated Washer Disinfectors due to possible overheating.
Distribution Pattern
USA Nationwide in the states of AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and internationally in Canada.
Code Information
Model # 46-4, Serial # range SEV0521184-SEV0838137