Recall Z-0908-03 ยท MEC Disinfector, Medical Devices
Getinge/Castle, Inc.
Model 8666 Washer/Disinfector with holding tank heater option. Firm on label is Getinge Disinfection AB, Vaxjo, Sweden.
| Date | Jun 5, 2003 (initiated Mar 25, 2003) |
| Status | Terminated |
| Reason | Hot water may splash from the washer chamber creating a burn hazard. |
| Root cause | Device Design |
| Action | Letter dated 3/25/03 flagged: ''Important Safety Alert/Product Upgrade''. Customers advised to discontinue use until the field correction is performed. |
| Quantity | 75 units |
| Distribution | Nationwide. Medical facilities in AL, CA, CO, LA, MA, MI, MN, MO, NC, NH, NM, OK, PA, TX, WA, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K920413 | DECOMAT A 8666 Getinge International, Inc., Apr 5, 1994 |