Agency classClass IOur severity:Severe FDA (Devices)·Z-0008-2014·Announced 2013-10-16

Draeger Fabius Anesthesia Machines Recalled for Electrical Clearance Defects

Draeger Medical is recalling 1,127 Fabius anesthesia machines worldwide because some units failed high-voltage tests and did not maintain minimum electrical clearance.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "During final testing of the Draeger Fabius GS Premium, Fabius OS, and Fabius Tiro anesthesia machines, some units did not pass the high voltage test and the minimum clearance between an electrical component and the unit housing was not…"

Plain-English summary

Draeger Medical, Inc. is recalling 1,127 units of the Draeger Fabius GS Premium, Fabius OS, Fabius Tiro, and Fabius Tiro D-M anesthesia machines. These devices are used to administer anesthesia and ventilation to patients during surgical procedures. The recall covers units distributed in the United States and numerous countries worldwide, including Argentina, Australia, Canada, China, France, Germany, India, Japan, and the United Kingdom.

The recall was initiated because during final testing, some units did not pass the high-voltage test. Additionally, the minimum clearance between an electrical component and the unit housing was not maintained for some units from a specific batch. This defect poses a potential electrical safety risk.

Healthcare facilities and users should identify affected units by checking the part numbers (8607000, 8606000, 8608400) and specific lot numbers listed in the official recall notice. Users should contact Draeger Medical, Inc. for instructions on how to proceed with the recall.

The recalled product

Product: Draeger Fabius GS Premium, Fabius OS, Fabius Tiro, Fabius Tiro D-M Product Usage: used to administer anesthesia and ventilation to patients during surgical procedures.
Manufacturer: Draeger Medical, Inc.
Category: Medical Device — Anesthesia Machine
Hazard: electrical-shock
electrical-clearance
Affected units: 1,127

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 (20)

ASED-0006
ASED-0074
ASED-0291
ASEC-0056
ASEC-0205
ASED-0007
SED-0075 ASED-0292
ASEC-0061
ASEC-0206
ASED-0020
ASED-0079
ASED-0293
ASEC-0062
ASEC-0207
ASED-0021
ASED-0139
ASED-0294
ASEC-0070
ASEC-0208
ASED-0023

Distribution

Distributed nationwide across the United States.

Same manufacturer · Draeger Medical, Inc.

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