Z-1374-2022Class II

Ventana HE 600 System, automated slide preparer, for use in laboratories

Name: Z-1374-2022 Ventana HE 600 System, automated slide preparer, for use in laboratories
Creator: Ventana Medical Systems Inc
Published: 2022-06-01
License: https://open.fda.gov/license/

Ventana Medical Systems Inc / initiated 2022-06-01 / Open, Classified

FDA source

Ventana Medical Systems Inc began a recall of Ventana HE 600 System, automated slide preparer, for use in laboratories on 2022-06-01. FDA classified it as Class II and gives the reason as "There is a potential for fluid leak inside the Ventana HE 600 instrument which could result in electrical short and fire". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1374-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-06-01
Posted: 2022-07-12
Recalling firm: Ventana Medical Systems Inc
Product: Ventana HE 600 System, automated slide preparer, for use in laboratories.
Product code: KPA Slide Stainer, Automated
Reason for recall: There is a potential for fluid leak inside the Ventana HE 600 instrument which could result in electrical short and fire
FDA 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 in commerce: 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
Product codes and lots: All Lots; UDI/DI: 04015630976010

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1374-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1374-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-07-20	2022-07-12

Product code KPA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)