Class I — Draeger Medical, Inc.
| Recalling firm | Draeger Medical Systems, Inc. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class I |
| Status | Terminated |
| Reason | During final testing of the Draeger Fabius GS Premium, Fabius OS, and Fabius Tiro anesthesia machines, some units did not pass the high voltage test and the minimum clearance between an electrical component and the unit housing was not maintained for some from a specific batch. |
| Product | Draeger Fabius GS Premium, Fabius OS, Fabius Tiro, Fabius Tiro D-M Product Usage: used to administer anesthesia and ventilation to patients during surgical procedures. |
| Quantity | 1127 units |
| Distribution | Worldwide distribution: US (nationwide) and countries of: Argentina, Australia, Austria, Azerbaijan, Bangladesh, Brazil, Bulgaria, Canada, Chile, China, Columbia, Ecuador, Egypt, France, Germany, Greece, Hungary, India, Indonesia, Israel, Italy, Ivory Coast, Japan, Kazakhstan, Latvia, Libya, Lithuania Malaysia, Morocco, Myanmar, Nepal, Philippines, Poland, Rumania, Russian Fed., Saudi Arabia, Se… |
| Initiated | 2013-08-14 |
| Classified | 2013-10-10 |
| Terminated | 2014-09-23 |
| Recall number | Z-0008-2014 |
| 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 I recall — Draeger Medical, Inc. (Z-0008-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/66025/
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