Class 2 Device Recall Ventana HE 600 System

• Date Initiated by Firm: June 01, 2022
• Date Posted: July 12, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1374-2022
• Recall Event ID: 90363
• Product Classification: Slide stainer, automated - Product Code KPA
• Product: Ventana HE 600 System, automated slide preparer, for use in laboratories.
• Code Information: All Lots; UDI/DI: 04015630976010
• FEI Number: 1000125183
• Recalling Firm/ Manufacturer: Ventana Medical Systems Inc; 1910 E Innovation Park Dr; Oro Valley AZ 85755-1962
• For Additional Information Contact: Roche Customer Support Center; 1800-227-2155
• Manufacturer 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 Determined 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
• 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.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.