Z-1924-2011

Quest MPS and MPS 2 Consoles, Quest Medical, Inc., An Atrion company. Single software controlled device that...

Name: Z-1924-2011 Quest MPS and MPS 2 Consoles, Quest Medical, Inc., An Atrion company. Single software controlled device that...
Creator: Quest Medical, Inc
Published: 2010-07-29
License: https://open.fda.gov/license/

Quest Medical, Inc / initiated 2010-07-29 / Terminated

FDA source

Quest Medical, Inc began a recall of Quest MPS and MPS 2 Consoles, Quest Medical, Inc., An Atrion company. Single software controlled device that incorporates a pump, a heater/cooler, temperature... on 2010-07-29. The reason FDA records is "User update regarding installation of external heater-Cooler units with MPS and MPS2 consoles". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1924-2011
Status: Terminated
Initiated: 2010-07-29
Posted: 2011-04-08
Terminated: 2011-04-26
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.
Product code: DTR Heat-Exchanger, Cardiopulmonary Bypass
Reason for recall: User update regarding installation of external heater-Cooler units with MPS and MPS2 consoles.
FDA 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 in commerce: 771 consoles
Distribution: Nationwide, Canada, Saudi Arabia, Kuwait, Japan, and Italy
Product codes and lots: 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

Product code DTR

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)