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Recall Observatory FDA recall evidence

Device product

BenchMark ULTRA and DISCOVERY ULTRA Instruments

Z-0894-2022

January 20, 2022

Class II

Product summary

Firm
Ventana Medical Systems Inc
Event
Event 89727
Status
Ongoing
Classification
Class II
Quantity
9214
Official record key
device-enforcement:Z-0894-2022

Official wording

Reason: Potential for Fluid Leak inside a staining system that could cause an electrical short circuit of the General Purpose Input/ Output Board's J1 Connector that could result in smoke and fire.

Code information: Serial Numbers Less-Than-Or-Equal-To 322030

Distribution pattern: US: CA, IL, PA, FL, AZ, NY, OH, CO, AR, NC, MD, AL, AK, LA, IA, MN, MA, ND, IN, TX, TN, CT, SC, GA, UT, WI, VA, SD, KY, MS, MO, DE, MI, MT, NJ, WV, OK, WA, OR, PR, DC, NM, ID, NH, NE, ME, KS, HI, NV, RI, WY, VT OUS: Australia, Austria, Belgium, Canada, China, Croatia, Denmark, Finland, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Japan, Netherlands, Norway, Poland, Portugal, Russian Fed., Singapore, South Korea, Spain, Sweden, Switzerland, United Kingdom, Algeria, Argentina, Aruba, Bosnia-Herzegovina., Brazil, Bulgaria, Chile, Colombia, Costa Rica, Cuba, Cyprus, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Greece, Indonesia, Ireland, Kazakhstan, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Macedonia, Malaysia, Martinique, Mexico, Monaco, Morocco, Namibia, New Zealand, Oman, Pakistan, Panama, Peru, Philippines, Reunion, Romania, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, Vietnam, White Russia, Zimbabwe

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential for Fluid Leak inside a staining system that could cause an electrical short circuit of the General Purpose Input/ Output Board's J1 Connector that could result in smoke and fire.