[Recalled] 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. — During final testing of the Draeger Fabius GS Premium
This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.
Recall details
| 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. |
|---|---|
| Brand / manufacturer | Draeger Medical, Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0008-2014 |
| Country of notice | United States |
| Risk level | Class I |
| Hazard type | recall |
| Notice date | 14 August 2013 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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.
This Class I recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Stop using the product immediately and follow the authority's remedy (return, repair, or disposal).
Read the full official notice →
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This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.