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.
Recall
- Recall Number
- Z-0018-2014
- Event Number
- 66000
- Firm
- Getinge Disinfection Ljungadalsgatan
- FEI Number
- 3000231474
- Product Code
- MEC
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- July 30, 2013
- Posted
- October 17, 2013
- Terminated
- May 11, 2015
- Address
- 11 Vaxjo Sweden
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.
Getinge Disinfection AB initiated a voluntary field safety correction for the Getinge 46-Series electrically-heated Washer Disinfectors due to possible overheating.
Getinge USA, Inc. sent a Device Correction Notices letter dated July 26, 2013 to all affected customers via US Postal Certified Mail within the U.S. and Canada. The letter identified the affected product, problem and actions to be taken. The letter indicate that all customers will be contacted by a Getinge representative for guidance if any machine within the serial number range of affected product is within their possession. If you should have any questions or concerns regarding this field correction, please call 1-800-475-9040, press "1" and enter extension 5036.
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.
143 units (142 domestically & 1 unit internationally)