Ventana Medical Systems Inc: BenchMark ULTRA and DISCOVERY ULTRA Instruments

Recall number

Z-0894-2022

Recalling firm

Ventana Medical Systems Inc

Product

BenchMark ULTRA and DISCOVERY ULTRA Instruments

Status

Open, Classified

Initiated

2022-01-20

Posted

2022-04-08

Terminated

not on file

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.

Root cause

Device Design

Action

On 01/20/22, correction notices were sent to customers who were asked to take the following actions needed to continue affected device use: 1) Inform any operators of the potential hazards associated with this issue and provide a copy of this notification as appropriate. 2) Inspect the instrument daily for evidence of leaks (i.e., liquid on the floor, or in and around the instrument). 3) If you experience a fluid leak, stop using the system and turn off the power to the instrument. Immediately contact the firm's Network Customer Support Center at 1-800-227-2155. 4) Complete the attached fax back form and return via fax or email. 5) If your facility has distributed the affected product to another site, please ensure this UMDC is provided to that site. 6) File this UMDC for future reference. The firm will send a representative to schedule a visit to perform an inspection, reroute cables, and replace parts as necessary to help mitigate the issue. Customers with questions were encouraged to call the Customer Support Center at the before mentioned number; support is available 24 hours a day, seven days a week. On 4/19/23, correction notices were distributed to additional customers who may have received devices without a drip loop, which is the solution to this event. Customers were told they would be contacted by a Service Representative to coordinate specific service actions, including the inspection of GPIO boards and rerouting cables - drip loop introduction.

Quantity

9214

Distribution

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

Lot, serial or model codes

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

510(k) numbers

not on file

PMA numbers

not on file

Product code

KPA

Firm FEI

1000125183

Firm city

Oro Valley

Firm state

AZ

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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