Agency classClass IIOur severity:Critical FDA (Devices)·Z-2250-2018·Announced 2018-06-27

Draeger Fabius GS Premium Anesthesia Machine Recalled for Hypoxia Risk

Draeger Medical is recalling 62 Fabius GS Premium Anesthesia Machines because a fault could allow the device to deliver a hypoxic gas mixture to patients.

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) classification.

Plain-English summary

Draeger Medical, Inc. is recalling 62 units of the Fabius GS Premium Anesthesia Machine (Catalog No. 8607000). These devices are used in operating, induction, and recovery rooms to administer inhalation anesthesia using oxygen, nitrous oxide, and air.

The recall is issued because 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.

The affected units were distributed nationwide to healthcare facilities in 33 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. Healthcare facilities should identify affected units by checking the specific serial numbers listed in the recall documentation and contact Draeger Medical for instructions on corrective action.

The recalled product

Product: Fabius GS Premium Anesthesia Machine; Cat. no. 8607000 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
gas-mixture-error
Affected units: 62

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