Ventilator System SERVO-i V3.1 PC1777 Maquet Critical Care
FDA device recall Z-0372-2007 · posted 2007-01-25 · Terminated
Recall details
- Recalling firm
- MAQUET Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- CBK
- Quantity affected
- 1, 970 units
- Distribution
- Worldwide
- Date initiated
- 2006-05-23
- Date posted
- 2007-01-25
- Date terminated
- 2008-04-11
- Location
- Bridgewater, NJ
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407E (K010925) | Siemens Elema AB | 2001-12-18 |