Ventana HE 600 System, automated slide preparer, for use in laboratories.
- Company
- Ventana Medical Systems Inc
- Recall Initiated
- June 1, 2022
- Posted
- July 12, 2022
- Recall Number
- Z-1374-2022
- Quantity
- 763 instruments
- Firm Location
- Oro Valley, AZ
Reason for Recall
There is a potential for fluid leak inside the Ventana HE 600 instrument which could result in electrical short and fire
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, Switzerland, Turkey, UK, Argentina, Australia, Brazil, Chile, China, Colombia, Costa Rica, Ecuador, Egypt, El Salvador, Guatemala, Hong Kong, Israel, Japan, Kuwait, Lebanon, Malaysia, Saudi Arabia, Singapore, South Korea, Taiwan, Thailand, United Arab Emirates (UAE), Vietnam
Lot / Code Info
All Lots; UDI/DI: 04015630976010
Root Cause
Under Investigation by firm
Action Taken
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 place the system in stand-by mode overnight when unattended until further mitigation actions have been implemented. 4. If fire is detected, follow your local emergency guidelines. 5. If a leak, smoke, or odor is detected in your VENTANA HE 600 instrument, power off the instrument immediately and call the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-227-2155. 6. Complete the enclosed faxback form (TP-01573) and return it according to the instructions on the form. 7. File this Urgent Medical Device Correction (UMDC) for future reference. 8. Adverse events or quality problems experienced with the use of this product may also be reported to the FDA s MedWatch Adverse Events Reporting Program: Online at http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm (form available to fax or mail), or call FDA 1-800-FDA-1088.