Recall Z-0894-2022 ยท KPA Slide Stainer, Automated
Ventana Medical Systems Inc
BenchMark ULTRA and DISCOVERY ULTRA Instruments
| Date | Apr 8, 2022 (initiated Jan 20, 2022) |
| Status | Open, Classified |
| 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 ba |
| 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, Germ |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.