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U.S. Department of Health and Human Services

Class 2 Device Recall VENTANA HE 600 system

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  Class 2 Device Recall VENTANA HE 600 system see related information
Date Initiated by Firm October 04, 2019
Create Date June 05, 2020
Recall Status1 Completed
Recall Number Z-2262-2020
Recall Event ID 85526
Product Classification Slide stainer, automated - Product Code KPA
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
Code Information All lots
Recalling Firm/
Manufacturer		 Ventana Medical Systems Inc
1910 E Innovation Park Dr
Oro Valley AZ 85755-1962
For Additional Information Contact Todd Siesky
925-730-8114
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 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 in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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