Servo Ventilator 300 (Model SV300) and Servo Ventilator 300 (Model SV300A). The SV300 is intended for general and critic
FDA device recall Z-1252-2009 · posted 2009-05-12 · Terminated
Recall details
- Recalling firm
- MAQUET Inc.
- Reason for recall
- The expiratory valve in the SV 300 ventilator may stay in the open position if the printed circuit board fails.
- Action taken
- An "Urgent: Device Correction" letter dated March 23, 2009 was sent by Federal Express to customers. The letter described the affected product, problem, indications, potential hazard and actions for users. Customers were instructed to complete the "Device Correction -- Customer Fax Response" form and return via fax (732-667-1903) to Maquet Inc. RA/QA. Direct questions to your local Maquet Inc. representative.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- CBK
- Quantity affected
- 7,847 units
- Distribution
- Nationwide Distribution.
- Date initiated
- 2009-03-23
- Date posted
- 2009-05-12
- Date terminated
- 2009-11-16
- Location
- Bridgewater, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SERVO VENTILATOR 300A (K970839) | Siemens Elema AB | 1997-10-14 |
| SERVO VENTILATOR 300 (K902859) | Siemens Life Support Systems | 1991-04-26 |