Recall Z-1374-2022 ยท KPA Slide Stainer, Automated
Ventana Medical Systems Inc
Ventana HE 600 System, automated slide preparer, for use in laboratories.
| Date | Jul 12, 2022 (initiated Jun 1, 2022) |
| Status | Open, Classified |
| Reason | There is a potential for fluid leak inside the Ventana HE 600 instrument which could result in electrical short and fire |
| Root cause | Under Investigation by firm |
| Action | On June 6, 2022 Ventana Medical Systems, Inc. (via Roche Diagnostics Corp.) issues an "Urgent Medical Device Correction" notification to affected consignees. Ventana Medical ask consignees to take the following actions: 1. Notify all operators of this potential hazard and forward this UMDC as appropriate. If your facility has distributed the affected device to another site, please ensure this UMDC is provided to that site. 2. Do not leave the instrument unattended when the power is on. Turn off the power to the instrument when it is unattended per the instructions in this UMDC. 3. Do not pl |
| Quantity | 763 instruments |
| Distribution | US: AL AR AZ CA CO CT DC FL GA HI IA IL IN KS KY MA MD MI MN MO MS MT NC NE NJ NY OH OK OR PA PR SC SD TN TX UT VA WA WI WV OUS: Canada, Austria, Belgium, Croatia, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Norway, Poland, Slovakia, Slovenia, Spain, Sweden, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.