Recall Z-1252-2009 ยท CBK Ventilator, Continuous, Facility Use
MAQUET Inc.
Servo Ventilator 300 (Model SV300) and Servo Ventilator 300 (Model SV300A). The SV300 is intended for general and critical ventilatory care for use on adults, pediatric, infant and neonatal patients. The unit is designed to be used at the bedside for intra-hospital transport.
| Date | May 12, 2009 (initiated Mar 23, 2009) |
| Status | Terminated |
| Reason | The expiratory valve in the SV 300 ventilator may stay in the open position if the printed circuit board fails. |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 7,847 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |