SERVO Ventilator 300A (SV300A); Maquet Critical Care Ab, Solna, Sweden. The device is intended for general and critical
FDA device recall Z-0872-2009 · posted 2009-02-03 · Terminated
Recall details
- Recalling firm
- MAQUET Inc.
- Reason for recall
- SERVO Ventilator 300A could cause hypoventilation if the use of the PC or PRVC mode with the Automode function set to "On" in Neonatal and Pediatric patient ranges with small tidal volumes and short set inspiratory rise time.
- Action taken
- URGENT: Device Correction letters were sent out on December 22, 2008. Letters alert users to the potential problem and the situation in which it may occur. Letter indicate the set inspiratory rise time should be set in the range of 7-10% and that the humidifier chamber water level be maintained according to manufacturers instructions. The letter is enclosed as a supplement to the SV300A Operating Manual. Consignees were directed to complete a "Device Correction-Customer Fax Response" to indicate number of units of the affected product and that they followed the instructions for including the attached supplemental instructions to the operating manual. For questions about the recall, contact your local Maquet, Inc. representative.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- CBK
- Quantity affected
- 3,688 units in US
- Distribution
- Nationwide
- Date initiated
- 2008-12-19
- Date posted
- 2009-02-03
- Date terminated
- 2009-07-08
- Location
- Bridgewater, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SERVO VENTILATOR 300A (K970839) | Siemens Elema AB | 1997-10-14 |