Z-0894-2022 Class II Ongoing

Recalled by Ventana Medical Systems Inc — Oro Valley, AZ

Recall Details

Product Type
Devices
Report Date
April 13, 2022
Initiation Date
January 20, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
9214

Product Description

BenchMark ULTRA and DISCOVERY ULTRA Instruments

Reason for Recall

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.

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

Code Information

Serial Numbers Less-Than-Or-Equal-To 322030