Ventana Medical Systems Inc BenchMark ULTRA and DISCOVERY ULTRA Instruments Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
BenchMark ULTRA and DISCOVERY ULTRA Instruments
Brand
Ventana Medical Systems Inc
Lot Codes / Batch Numbers
Serial Numbers Less-Than-Or-Equal-To 322030
Products Sold
Serial Numbers Less-Than-Or-Equal-To 322030
Ventana Medical Systems Inc is recalling BenchMark ULTRA and DISCOVERY ULTRA Instruments due to Potential for Fluid Leak inside a staining system that could cause an electrical short circuit of the General Purpose Input/ Output Board's J1 Connect. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY, DC, PR
Page updated: Jan 10, 2026