Draeger Fabius MRI Anesthesia Machine Recalled for Magnetic Field Attraction
Draeger Medical is recalling 373 Fabius MRI anesthesia machines because their parts can be loosened by the magnetic field of MRI equipment.
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 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 recall is classified as FDA Class II and involves a structural defect (parts loosening) in a critical medical device, which aligns with the 'Severe' criteria for significant injury risk or structural defects.
Plain-English summary
Draeger Medical, Inc. is recalling 373 units of the Fabius MRI Anesthesia Machine. This device is an inhalation anesthesia machine designed for use in MRI environments in operating, induction, and recovery rooms. The recall covers units distributed nationwide in the United States.
The recall is being conducted because the Fabius MRI or parts of the system can be attracted by the magnetic field of the MRI. If the machine is positioned too close to the MRI, its parts can be loosened as a result of the magnetic force.
Healthcare facilities that have purchased or received these units should contact Draeger Medical for instructions on how to proceed. The source text does not specify a deadline or additional remediation steps.
The recalled product
- Product
- Fabius MRI Anesthesia Machine; Fabius MRI is an inhalation anesthesia machine for use in MRI environments in operating, induction and recovery rooms.
- Manufacturer
- Draeger Medical, Inc.
- Affected units
- 373
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)
- Catalog Number(s): 8607300
Distribution
Distributed nationwide across the United States.
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