Recall Z-2262-2020 ยท KPA Slide Stainer, Automated
Ventana Medical Systems Inc
Model Number: 06917259001 UDI: 04015630976010 - Product Usage: The System s intended use environment includes anatomic pathology (AP) laboratories and histology facilities within hospital, clinic, reference, or private lab settings. The System is to be operated by qualified users in
| Date | Oct 4, 2019 |
| Status | Completed |
| Reason | The firm became aware of a cleaning solution leaking issue from the middle staining module of the Ventana HE 600 instrument, used for histologic section samples in anatomic pathology laboratory settings, which caused fluid to travel down to the electrical wiring connector of the Coverslipper solvent shield circuit board. This can cause an electrical short and result in burned components. |
| Root cause | Under Investigation by firm |
| Action | All US consignee accounts who are utilizing the VENTANA HE 600 system were to receive a copy of the Urgent Medical Device Correction (UMDC) notification, VENTANA HE 600 Instrument - Fluid Leak and Risk of Burned Components, via UPS Ground on 10/16/19. It notified user that Roche Tissue Diagnostics received notification of an issue on the VENTANA HE 600 instrument. A leak from the middle staining module caused fluid to travel down to the electrical wiring connector of the Coverslipper solvent shield circuit board. This caused an electrical short and resulted in burned components. It stated cli |
| Quantity | 461 |
| Distribution | Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, MD, MI, MA, MN, MO, MS, MT, NC, NE, NJ, NY, OH, OK, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI and the countries of Australia, Austria, Belgium, Brazil, Canada, Chile, C |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.