Getinge Disinfection: Medical Device Recall in 2013 - (Recall #: Z-0018-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: July 30, 2013

Date Posted: October 23, 2013

Recall Number: Z-0018-2014

Event ID: 66000

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.

Status: Terminated

Product Quantity: 143 units (142 domestically & 1 unit internationally)

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.

Voluntary or Mandated:

Voluntary: Firm initiated