Recall Z-1224-2015 ยท CBN Apparatus, Gas-Scavenging
Maquet Cardiovascular Us Sales, Llc
Servo-I ventilator system CO2 analyzer. Part number 65 23 588.
| Date | Feb 27, 2015 (initiated Jan 12, 2015) |
| Status | Terminated |
| Reason | A calibration problem was detected in a specific number of the Servo-I ventilator system CO2 analyzer models that may have been caused by the module's internal circuit board function. |
| Root cause | Device Design |
| Action | Maquet sent an Urgent Product Recall Medical Device Action Field Removal Letter dated 1/12/2015 via FedEx. |
| Quantity | 486 units |
| Distribution | Worldwide distribution - USA nationwide, Austria, Australia, Belgium, Chile, Canada, Colombia, Ecuador, Egypt, Finland, France, Germany, Hungary, Iceland, India, Indonesia, Iraq, Italy, Japan, Libya, Netherlands, Norway, Panama, Peru, Portugal, Romania, Russia, Saudi Arabia, South Africa, Spain, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123149 | SERVO-I VENTILATOR SYSTEM Maquet Critical Care AB, Jun 20, 2014 |