FDA Medical Device Recalls (openFDA)
Ventana Medical Systems Inc: Discovery XT, Slide Staining System, Catalog Number: N750-DISXT-FS, Ventana Medical Systems Inc, Tucson, AZ
- Recall number
- Z-0541-2008
- Recalling firm
- Ventana Medical Systems Inc
- Product
- Discovery XT, Slide Staining System, Catalog Number: N750-DISXT-FS, Ventana Medical Systems Inc, Tucson, AZ
- Status
- Terminated
- Initiated
- 2006-09-29
- Posted
- 2008-01-24
- Terminated
- 2013-06-06
- Reason
- Leaking Carboys/Safety Updates:The Ventana Staining Platform includes one or more carboys that may have the potential to leak if the spigot is either improperly installed or not fully closed.
- Root cause
- Device Design
- Action
- The firm has mailed three customer letters, a) the first letter dated 9/30/2005 describes the upgraded Voila CD that contains safety information; b) a second letter, dated 6/27/2006, identified as a "Customer Alert" was mailed describing an upgrade to the software system version 9.3/10.3 and the CD that includes safety improvements, c) the third letter dated 9/29/2006 and identified as a Safety Alert advises that as part of their effort to continuously improve laboratory safety, they are updating the labeling and instructions for use regarding installation and cleaning for the carboy as the Ventana staining platform includes one or more carboys that may have the potential to leak if the spigot is either improperly installed or not fully closed. Enclosed are pictogram labels that indicate "slip hazard" and "refer to instructions for use." The customer is instructed to apply these two labels to the carboys above the spigot as a reminder to laboratory personnel to keep the spigot in the full "off" position when not in use and to refer to the instructions for use for maintenance. In addition, the letter advises that there is an electrical shock warning for the power strip that is part of their system to indicate that it should be mounted off of the floor. This power strip is intended to connect the computer components of the staining system and should not be placed on the floor where fluid might contact it. Also included is a warning label for shock hazard to apply to their power strip.
- Quantity
- USA - 1,712 units; Foreign - 1,159 units (total for recalls-Z-0537-0541-2008)
- Distribution
- Worldwide; USA, Australia, China, Canada, Germany, Great Britain, France, Italy, Hungary, Singapore, Korea, Taiwan, Spain, Poland, Greece, Austria, Sweden, Japan, Israel, Denmark, Turkey, Finland, Saudi Arabia, The Netherlands, Norway, Slovenia, Ireland, and Belgium
- Lot, serial or model codes
- Serial Numbers: #710000-711288
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KPA
- Firm FEI
- 1000125183
- Firm city
- Tucson
- Firm state
- AZ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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