Recall Z-0571-05 ยท CBK Ventilator, Continuous, Facility Use
Maquet Inc
Servo-Ventilator, SV300/300A, Part numbers 6070391 and 6424704. The Safety Alert action targets customers with Unit Serial numbers 24578 and lower. Manuf. Maquet Critial Care AB, SE-171 95 Solna, Sweden.
| Date | Mar 8, 2005 (initiated Jan 3, 2005) |
| Status | Terminated |
| Reason | Failures of the air and oxygen gas modules occurred because of misuse/non-compliance of directions. |
| Root cause | Other |
| Action | Customer letter mailed on January 3, 2005 via certified postage, with return self-addressed postcards that customers must complete to acknowledge receipt of the instructions to refer to their Service and Operating Manuals. |
| Quantity | 7920 units |
| Distribution | The ventilators were distributed to hospitals nationwide. There are 33 VA Medical Center and DOD hospitals nationwide. |
| FDA record | Open on fda.gov |