FDA Medical Device Recalls (openFDA)
Ventana Medical Systems Inc: Symphony Staining System (High Volume Stainer), KPA, Model Number 2200000, Ventana Medical Systems Inc
- Recall number
- Z-0553-2008
- Recalling firm
- Ventana Medical Systems Inc
- Product
- Symphony Staining System (High Volume Stainer), KPA, Model Number 2200000, Ventana Medical Systems Inc
- Status
- Terminated
- Initiated
- 2007-10-30
- Posted
- 2008-01-25
- Terminated
- 2008-04-14
- Reason
- Fluid Leaks-The T fitting located in the Symphony Clear system of the Symphony High Volume Slide Stainer needs to be larger to securely hold the tubing in place to eliminate any possible fluid leak due to the tubing movement.
- Root cause
- Component design/selection
- Action
- The end user customers were verbally contacted starting in November 2007 to set up a scheduled visit to replace the fitting.
- Quantity
- 55
- Distribution
- Worldwide-USA, France and Japan
- Lot, serial or model codes
- 910044, 910020, 910041, 910060, 910038, 910008, 910048, 910029, 910057, 910006, 910027, 910049, 910036, 910011, 910014, 910056, 910022, 910019, 910016, 910046, 910042, 910007, 910053, 910031, 910021, 910037, 910077, 910032, 910023, 910028, 910034, 910054, 910025, 910045, 910001, 910002, 910015, 910017, 910018, 910026, 910030, 910043, 910004, 910024, 910003, 910047, PP-018, 910040, 910033, 910058, 910059, 910009, 910010, 910013, PP-017
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KEY
- 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