Recall Z-2443-2008 ยท CBK Ventilator, Continuous, Facility Use
MAQUET Inc.
SERVO-s Ventilator System, Maquet Critical Care, Solna, Sweden. The product is intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory failure or respiratory insufficiency.
| Date | Sep 23, 2008 (initiated Jul 8, 2008) |
| Status | Terminated |
| Reason | Maquet became aware of potentially defective crimpings at the point connector attached to the cable in SERVO-i and SERVO-s ventilators. |
| Root cause | Employee error |
| Action | Urgent - Device Correction notices were sent out to all customers on July 7, 2008. The letter informed the customers of the affected product, and associated hazards. The letter instructed customers to take an inventory of the product and it provided actions to be taken until affected products are replaced. Contact Maquet at 1-888-627-8383#1, for assistance. |
| Quantity | 122 total (SERVO-i and SERVO-s) in US. |
| Distribution | Worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041223 | MODIFICATION TO SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E Maquet Critical Care AB, Jul 29, 2004 |