Fabius Tiro M — Class I medical device recall Z-1484-2018
Terminated recall by Draeger Medical, Inc., reported 2018-05-16, distributed nationwide. The automatic ventilation may fail if the position detection of the motor is disturbed. If the ventilator cove
| Recall number | Z-1484-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Draeger Medical, Inc., Telford, PA, United States |
| Recall initiated | 2018-03-01 |
| Classified | 2018-05-07 |
| Reported by FDA | 2018-05-16 |
| Terminated | 2019-04-16 |
| Distributed | Nationwide (US) |
| Quantity | 1 |
| Reason classes | device malfunction |
| Serial numbers | ASKK-0001 |
| Model numbers | 8608400 |
Product
Fabius Tiro M, anesthesia machine, catalog no. 8608400 Product Usage: The products are inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabius series anesthesia machines are equipped with an electrically driven and electronically controlled ventilator and monitors for airway pressure (P), volume (V), and inspiratory oxygen concentration (FiO2).
Reason for recall
The automatic ventilation may fail if the position detection of the motor is disturbed. If the ventilator cover is damaged, manual ventilation may also fail.
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-1484-2018. 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.