Recall Z-0372-2007 ยท CBK Ventilator, Continuous, Facility Use
MAQUET Inc.
Ventilator System SERVO-i V3.1 PC1777 Maquet Critical Care
| Date | Jan 25, 2007 (initiated May 23, 2006) |
| Status | Terminated |
| Reason | Reported failures of the SERVO-i ventilators user interface system causing technical errors and increased fault frequencies. Switches may be activated unintentionally, or a function not activate when the switch is selected. Direct access knobs may not function or change the parameter in the wrong direction compared to how they are turned. |
| Root cause | Other |
| Action | Maquet sent an ''Extended Warranty'' letter on May 23, 2006. On March 13, 2007, Maquet issued a Recall Notification letter to all customers stating that they will replace all PC1777 boards in the serial number range 2400-3300, which have not previously been replaced. A safety alert letter was included outlining the failure indication and effect for the user of the failures, as well as, how to identify whether the Servo-i unit has shown any failure indications. |
| Quantity | 1, 970 units |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010925 | SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407E Siemens Elema AB, Dec 18, 2001 |