Ventana Medical Systems Inc: Model Number: 06917259001 UDI: 04015630976010 - Product Usage: The System s intended use environment includes anatomic pathology (AP) laboratories and histology facilities within hospital, clinic, reference, or private lab settings. The System is to be operated by qualified users in

Recall number

Z-2262-2020

Recalling firm

Ventana Medical Systems Inc

Product

Model Number: 06917259001 UDI: 04015630976010 - Product Usage: The System s intended use environment includes anatomic pathology (AP) laboratories and histology facilities within hospital, clinic, reference, or private lab settings. The System is to be operated by qualified users in

Status

Completed

Initiated

2019-10-04

Posted

not on file

Terminated

not on file

Reason

The firm became aware of a cleaning solution leaking issue from the middle staining module of the Ventana HE 600 instrument, used for histologic section samples in anatomic pathology laboratory settings, which caused fluid to travel down to the electrical wiring connector of the Coverslipper solvent shield circuit board. This can cause an electrical short and result in burned components.

Root cause

Under Investigation by firm

Action

All US consignee accounts who are utilizing the VENTANA HE 600 system were to receive a copy of the Urgent Medical Device Correction (UMDC) notification, VENTANA HE 600 Instrument - Fluid Leak and Risk of Burned Components, via UPS Ground on 10/16/19. It notified user that Roche Tissue Diagnostics received notification of an issue on the VENTANA HE 600 instrument. A leak from the middle staining module caused fluid to travel down to the electrical wiring connector of the Coverslipper solvent shield circuit board. This caused an electrical short and resulted in burned components. It stated clinical significance that there is a remote possibility that use of the VENTANA HE 600 system would result in adverse health consequences. It advised users that Roche Service Representatives will remove the cable that conducts electricity to the Coverslipper Module LED PCBA, proactively replace the Stainer Exchange Valves, and proactively replace the 65 micron filters in the Cleaning Solution fluidics line. Site visits will be scheduled as appropriate. Customers can continue using the instrument as normal. However, if droplets are observed on the instrument Coverslip Module during normal operation: stop instrument operation, unplug the instrument, and contact your Roche Service Representative immediately. Actions Required: " If customers observe droplets on the instrument Coverslip Module during normal operation: stop instrument operation, unplug the instrument, and contact your Roche Service Representative immediately. " Complete attached fax form and fax or email it according to the instructions on the form. " File the Urgent Medical Device Correction (UMDC) for future reference. Customers can contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-227-2155 if they have questions about the information contained in the UMDC. Adverse events or quality problems experienced with the use of this product may also be reported to

Quantity

461

Distribution

Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, MD, MI, MA, MN, MO, MS, MT, NC, NE, NJ, NY, OH, OK, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI and the countries of Australia, Austria, Belgium, Brazil, Canada, Chile, China, Columbia, Costa Rica, Croatia, Denmark, Ecuador, El Salvador, Finland, France, Germany, Hong Kong, Ireland, Italy, Japan, Kuwait, Lebanon, Malaysia, Norway, Peru, Poland, Saudi Arabia, Slovakia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom, Vietnam.

Lot, serial or model codes

All lots

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

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

Copy