Ventana Medical Systems Inc Ventana HE 600 System, automated slide preparer, for use in laboratories. Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Ventana HE 600 System, automated slide preparer, for use in laboratories.
Brand
Ventana Medical Systems Inc
Lot Codes / Batch Numbers
All Lots, UDI/DI: 04015630976010
Products Sold
All Lots; UDI/DI: 04015630976010
Ventana Medical Systems Inc is recalling Ventana HE 600 System, automated slide preparer, for use in laboratories. due to There is a potential for fluid leak inside the Ventana HE 600 instrument which could result in electrical short and fire. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There is a potential for fluid leak inside the Ventana HE 600 instrument which could result in electrical short and fire
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AZ, AR, CA, CO, CT, FL, GA, HI, IL, IN, IA, KS, KY, MD, MA, MI, MN, MS, MO, MT, NE, NJ, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WV, WI, DC, PR
Page updated: Jan 10, 2026