Class II — Maquet Cardiovascular Us Sales, Llc
| Recalling firm | Maquet Cardiovascular LLC |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| 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. |
| Product | Servo-I ventilator system CO2 analyzer. Part number 65 23 588. |
| 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, Sweden, Thailand, Tunisia, Turkey, Ukraine, and United Kingdom. |
| Initiated | 2015-01-12 |
| Classified | 2015-02-27 |
| Terminated | 2017-05-15 |
| Recall number | Z-1224-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Maquet Cardiovascular Us Sales, Llc (Z-1224-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/70224/
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