Servo-I ventilator system CO2 analyzer. Part number 65 23 588.
FDA device recall Z-1224-2015 · posted 2015-02-27 · Terminated
Recall details
- Recalling firm
- Maquet Cardiovascular Us Sales, Llc
- Reason for recall
- 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.
- Action taken
- Maquet sent an Urgent Product Recall Medical Device Action Field Removal Letter dated 1/12/2015 via FedEx.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- CBN
- Quantity affected
- 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,
- Date initiated
- 2015-01-12
- Date posted
- 2015-02-27
- Date terminated
- 2017-05-15
- Location
- Wayne, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SERVO-I VENTILATOR SYSTEM (K123149) | Maquet Critical Care AB | 2014-06-20 |