Agency classClass IIOur severity:Critical FDA (Devices)·Z-2252-2018·Announced 2018-06-27

Draeger Fabius GS MRI Anesthesia Machine Recalled for Hypoxia Risk

Draeger Medical is recalling four Fabius GS MRI Anesthesia Machines because a fault could allow the device to deliver a hypoxic gas mixture to patients, potentially causing 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 four units of the Fabius GS MRI Anesthesia Machine (Catalog No. 8607300). The recall involves specific serial numbers: ASLA-0017, ASLA-0018, ASLA-0019, and ASLA-0020. These devices are used in operating, induction, and recovery rooms for inhalation anesthesia and are compatible with MRI scanner rooms.

The recall is due to a potential fault in the S-ORC module. If this fault occurs, the module may fail to prevent the setting of a nitrous oxide (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.

The affected units were distributed nationwide to healthcare facilities in the following states: 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. Healthcare facilities should contact Draeger Medical for instructions on how to address this issue.

The recalled product

Product: Fabius GS MRI Anesthesia Machine; Cat. no. 8607300 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: 4

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

ASLA-0017 ASLA-0018 ASLA-0019 ASLA-0020

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