FDA Medical Device Recalls (openFDA)
Quest Medical, Inc: Quest MPS and MPS 2 Consoles, Quest Medical, Inc., An Atrion company. Single software controlled device that incorporates a pump, a heater/cooler, temperature monitoring, pressure monitoring, a heat exchanger, an arrest agent pump and an additive pump. The MPS console is used with the MPS sterile disposables with a built in heat exchanger. The device is used with on-pump or off-pump cardiac surgery.
- Recall number
- Z-1924-2011
- Recalling firm
- Quest Medical, Inc
- Product
- Quest MPS and MPS 2 Consoles, Quest Medical, Inc., An Atrion company. Single software controlled device that incorporates a pump, a heater/cooler, temperature monitoring, pressure monitoring, a heat exchanger, an arrest agent pump and an additive pump. The MPS console is used with the MPS sterile disposables with a built in heat exchanger. The device is used with on-pump or off-pump cardiac surgery.
- Status
- Terminated
- Initiated
- 2010-07-29
- Posted
- 2011-04-08
- Terminated
- 2011-04-26
- Reason
- User update regarding installation of external heater-Cooler units with MPS and MPS2 consoles.
- Root cause
- Other
- Action
- Quest Medical Incorporated sent a "User Update" letter in July 2010 to consignees providing information concerning use of external heater-cooler untis with their device - Myocardial Protection System ( MPS) consoles. If you are installing an external heater-water cooler unit or have questions about this user update, please contact the Field Service department at Quest Medical, Inc. The number is 800.627.0026 or 1 972.390.9800.
- Quantity
- 771 consoles
- Distribution
- Nationwide, Canada, Saudi Arabia, Kuwait, Japan, and Italy
- Lot, serial or model codes
- MPS Serial Numbers: 2022, 2023, 2024, 2297, 2307, 2177, 2258, 2259, 2261, 2263, 2266, 2421, 2422, 1198, 1379, 1385, 1395, 2022, 2023, 2024, 2335, 2336, 2396, 9069, 1407, 1408, 1409, and 2078
- 510(k) numbers
- ["K041979","K953838"]
- PMA numbers
- not on file
- Product code
- DTR
- Firm FEI
- 3001665800
- Firm city
- Allen
- Firm state
- TX
- 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