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Ventana Medical Systems Inc Recall 89727

Description: BenchMark ULTRA and DISCOVERY ULTRA Instruments

Ventana Medical Systems Inc Recall 89727 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0894-2022
Event ID89727
Event DescriptionBenchMark ULTRA and DISCOVERY ULTRA Instruments
Product TypeDevices
DistributionUS: 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
Quantity8630
Recall ReasonPotential 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.
Device Classification20220413
Device Code InfoAll serial numbers
Center Classification Date20220407
Recall Initiation Date20220120
Recalling FirmVentana Medical Systems Inc
Initial Notification Letter
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