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Recall Observatory FDA recall evidence

Device product

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.

Z-0018-2014

July 30, 2013

Class II

Product summary

Firm
Getinge Disinfection
Event
Event 66000
Status
Terminated
Classification
Class II
Quantity
143 units (142 domestically & 1 unit internationally)
Official record key
device-enforcement:Z-0018-2014

Official wording

Reason: Getinge Disinfection AB initiated a voluntary field safety correction for the Getinge 46-Series electrically-heated Washer Disinfectors due to possible overheating.

Code information: Model # 46-4, Serial # range SEV0521184-SEV0838137

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Getinge Disinfection AB initiated a voluntary field safety correction for the Getinge 46-Series electrically-heated Washer Disinfectors due to possible overheating.