{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "181168", "product_res_number": "Z-2262-2020", "event_date_initiated": "2019-10-04", "event_date_created": "2020-06-05", "recall_status": "Completed", "res_event_number": "85526", "product_code": "KPA", "product_description": "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_info": "All lots", "firm_fei_number": "1000125183", "recalling_firm": "Ventana Medical Systems Inc", "address_1": "1910 E Innovation Park Dr", "city": "Oro Valley", "state": "AZ", "postal_code": "85755-1962", "additional_info_contact": "Todd Siesky\n925-730-8114", "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.", "root_cause_description": "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.\nCustomers 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. \nActions Required:\n\" 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.\n\" Complete attached fax form and fax or email it according to the instructions on the form.\n\" File the Urgent Medical Device Correction (UMDC) for future reference.\nCustomers 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.\nAdverse events or quality problems experienced with the use of this product may also be reported to", "product_quantity": "461", "distribution_pattern": "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.", "openfda": { "k_number": [ "K780637", "K811697", "K771699", "K821830", "K884258", "K933996", "K832994", "K881592", "K770076", "K853210", "K850333", "K781598", "K874887", "K771559", "K850157", "K880745", "K780017", "K872916", "K874897", "K842077", "K833295" ], "registration_number": [ "3003559191", "3017439370", "3033524192", "2916205", "1063851", "9680927", "3009432145", "3010889707", "3043138885", "3009189893", "3016621374", "3003423869", "9610099", "3020704087", "3009596884", "1640981", "3008776165", "3010685493", "3030509363", "3003601075", "3002805583", "3008505743", "3003639866", "3015167933", "3013059683", "3009746061", "1000303355", "1000138378", "2432235", "3014611360", "3016764932", "2030652", "3009448641", "3006606827", "3007648367", "2083544", "3006610913", "9613959", "8010478", "3010139432", "9615754", "3007035884", "3015614371", "3010461097", "3004140393", "1717966", "2022180", "2028492", "3031915160", "1222780", "3010188766", "8020030", "3004859032", "3038188821", "3010692993", "3003402518", "3043088937", "3027645317", "3005716001", "3003584784", "3009547954", "3013043616", "3002710220", "3019387954", "3010421384", "3006788232", "3010960914", "3011637800", "3000148879", "3016438761", "1061932", "9610806", "3009711478", "3038196622", "3009963993", "3006412379", "3006198300", "3005333358", "1000391282", "3043606682", "3009000266", "3014165737", "3020305854" ], "fei_number": [ "3003559191", "3007419242", "3017439370", "3033524192", "1000125183", "2916205", "2936532", "3010889707", "3043138885", "3009189893", "3016621374", "3003423869", "3020704087", "3009596884", "1640981", "3010685493", "3030509363", "3003601075", "3000203293", "3002805583", "3008505743", "3003639866", "3015167933", "3013059683", "3009746061", "1000303355", "1000138378", "1000442352", "2432235", "3014611360", "3016764932", "2244894", "3002179321", "3009448641", "3006606827", "3008237827", "3007648367", "2083544", "3006610913", "3002808301", "3010139432", "3006461677", "3007035884", "3015614371", "3010461097", "3004140393", "1717966", "2022180", "3031915160", "3010188766", "3004859032", "3038188821", "3010692993", "3003402518", "3043088937", "3027645317", "3000205059", "3005716001", "3003584784", "3009547954", "3013043616", "3002710220", "1000120743", "3019387954", "3010421384", "3006788232", "3010960914", "3011637800", "3000148879", "3016438761", "3001644026", "3009711478", "3038196622", "3009963993", "3006412379", "3006198300", "3005333358", "1000391282", "3043606682", "3009000266", "3014165737", "3020305854", "3002806778" ], "device_name": "Slide Stainer, Automated", "medical_specialty_description": "Pathology", "regulation_number": "864.3800", "device_class": "1" } } ] }