Recall Z-0589-2010 ยท CBK Ventilator, Continuous, Facility Use
MAQUET Inc.
Maquet Servo Ventilator SV900C/D/E (SV900) Siemens-Elema AB, Solna, Sweden
| Date | Jan 5, 2010 (initiated Nov 17, 2009) |
| Status | Terminated |
| Reason | Some Servo Ventilators 300/300A and Servo Ventilator 900C/D/E should not be used with a system that may generate negative pressure below -100 cm H2O (Closed system suctioning) due to the risk of damaging the ventilator's pressure transducers. |
| Root cause | Device Design |
| Action | Maquet sent Device Correction letters commencing 11/17/09 and ending 11/23/09 by Federal Express. |
| Quantity | 29364 (8438 of those in US) |
| Distribution | Worldwide distribution |
| FDA record | Open on fda.gov |