FDA Medical Device Recalls (openFDA)
Ventana Medical Systems Inc: Ventana HE 600 System, automated slide preparer, for use in laboratories.
- Recall number
- Z-1374-2022
- Recalling firm
- Ventana Medical Systems Inc
- Product
- Ventana HE 600 System, automated slide preparer, for use in laboratories.
- Status
- Open, Classified
- Initiated
- 2022-06-01
- Posted
- 2022-07-12
- Terminated
- not on file
- 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 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.
- 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, 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, serial or model codes
- All Lots; UDI/DI: 04015630976010
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KPA
- Firm FEI
- 1000125183
- Firm city
- Oro Valley
- Firm state
- AZ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28