Quest MPS and MPS 2 Consoles, Quest Medical, Inc., An Atrion company. Single software controlled device that incorporate
FDA device recall Z-1924-2011 · posted 2011-04-08 · Terminated
Recall details
- Recalling firm
- Quest Medical, Inc
- Reason for recall
- User update regarding installation of external heater-Cooler units with MPS and MPS2 consoles.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DTR
- Quantity affected
- 771 consoles
- Distribution
- Nationwide, Canada, Saudi Arabia, Kuwait, Japan, and Italy
- Date initiated
- 2010-07-29
- Date posted
- 2011-04-08
- Date terminated
- 2011-04-26
- Location
- Allen, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MPS MYOCARDIAL PROTECTION SYSTEM - MPS 2 CONSOLE, MODEL 5201260 (K041979) | Quest Medical, Inc. | 2004-09-02 |
| MYOCARDIAL PROTECTION SYSTEM (K953838) | Quest Medical, Inc. | 1996-03-06 |