Draeger Fabius GS Premium — Class I medical device recall Z-0008-2014
Terminated recall by Draeger Medical, Inc., reported 2013-10-16, distributed nationwide. During final testing of the Draeger Fabius GS Premium, Fabius OS, and Fabius Tiro anesthesia machines, some un
| Recall number | Z-0008-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Draeger Medical, Inc., Telford, PA, United States |
| Recall initiated | 2013-08-14 |
| Classified | 2013-10-10 |
| Reported by FDA | 2013-10-16 |
| Terminated | 2014-09-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BD, BG, BR, CA, CH, CL, CN, DE, EC, EG, ES, FR, GB, GR, HU, ID, IL, IN, IT, JP, KR, LT, LV, MA, MY, NP, PH, PL, RU, SA, SE, TR, TW, UY, VN, ZA |
| Quantity | 1,127 units |
| Lot numbers | ASEB-0219, ASEC-0054, ASEC-0056, ASEC-0061, ASEC-0062, ASEC-0070, ASEC-0071, ASEC-0112, ASEC-0124, ASEC-0125, ASEC-0126, ASEC-0167, ASEC-0169, ASEC-0170, ASEC-0171, ASEC-0172, ASEC-0173, ASEC-0174, ASEC-0175, ASEC-0176, ASEC-0178, ASEC-0179, ASEC-0180, ASEC-0181, ASEC-0182, ASEC-0183, ASEC-0184, ASEC-0185, ASEC-0186, ASEC-0193, ASEC-0194, ASEC-0195, ASEC-0196, ASEC-0197, ASEC-0205, ASEC-0206, ASEC-0207, ASEC-0208, ASEC-0209, ASEC-0210 and 111 more |
| Model numbers | 8607000 |
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0008-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.