# FDA recall Z-1483-2018

> **Draeger Medical, Inc.** · Class I · device recall initiated 2018-03-01.

## Product

Fabius Tiro, anesthesia machine, catalog no. 8606000    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.

## Distribution

US Nationwide Distribution to accounts in 21 states: AZ, CA, CO, ID, IL, KS, MA, MI, MS, NC, NY, OH, OK, PA, RI, TN, TX, UT, VA, WA, WI; and PR.

## Key facts

- **Recall number:** Z-1483-2018
- **Recalling firm:** Draeger Medical, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-03-01
- **Report date:** 2018-05-16
- **Termination date:** 2019-04-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Telford, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1483-2018

## Citation

> AI Analytics. FDA recall Z-1483-2018. Retrieved 2026-05-29 from https://api.ai-analytics.org/recall/Z-1483-2018. Source: US FDA. Licensed CC0.

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