Recall Z-0018-2014 ยท MEC Disinfector, Medical Devices
Getinge Disinfection
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.
| Date | Oct 17, 2013 (initiated Jul 30, 2013) |
| Status | Terminated |
| Reason | Getinge Disinfection AB initiated a voluntary field safety correction for the Getinge 46-Series electrically-heated Washer Disinfectors due to possible overheating. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 143 units (142 domestically & 1 unit internationally) |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.