Agency classClass IIOur severity:Critical FDA (Devices)·Z-2251-2018·Announced 2018-06-27

Draeger Fabius GS Tiro Anesthesia Machine Recalled for Hypoxia Risk

Draeger Medical is recalling 31 Fabius GS Tiro anesthesia machines because a fault could allow 100% nitrous oxide delivery, creating a risk of hypoxic mixtures and patient death.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The source text explicitly states that potential adverse outcomes include death of the patient, which meets the rubric criteria for a Critical (Score 5) severity rating.

Plain-English summary

Draeger Medical, Inc. is recalling 31 units of the Fabius GS Tiro Anesthesia Machine (Catalog No. 8606000). These devices are used in operating, induction, and recovery rooms for inhalation anesthesia. The recall affects units distributed to healthcare facilities in 33 U.S. states, including AK, AL, AZ, CA, CO, FL, GA, IA, IL, IN, MA, MD, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, TN, TX, UT, WA, WI, and WV.

The recall is due to a potential defect where the device may be able to dose 100% nitrous oxide (N2O). In the event of a fault, the S-ORC module would not prevent setting an N2O flow that results in a hypoxic mixture being delivered to the patient. The source text states that potential adverse outcomes include death of the patient.

Healthcare facilities should stop using the affected units and contact Draeger Medical for instructions on the recall. The specific serial numbers or lot codes for the affected units are listed in the agency's structured data, including codes such as ASKM-0110, ASKM-0111, and ASKN-0032.

The recalled product

Product: Fabius GS Tiro Anesthesia Machine; Cat. no. 8606000 Product Usage: 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.…
Manufacturer: Draeger Medical, Inc.
Category: Medical Device — Anesthesia Machine
Hazard: hypoxia
death
Affected units: 31

Distribution

Distributed nationwide across the United States.

The notice also names 33 states specifically:

Part of a larger recall action

This product is one of 5 recalled by Draeger Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Same manufacturer · Draeger Medical, Inc.

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Same hazard · hypoxia