Draeger Fabius MRI Anesthesia Machines recalled due to misrouted oxygen hoses
Draeger Medical recalls 26 Fabius MRI Anesthesia Machines due to incorrectly routed internal oxygen hoses. The misrouting can cause oxygen flow to deviate from set levels, risking inadequate patient oxygenation.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm medical device with potential for serious patient harm (hypoxia during anesthesia) but no illnesses or injuries reported to date. Although FDA Class II, it lacks the hospitalization or injury reports required for Score 4, placing it at Score 3 per the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
Draeger Medical, Inc. is recalling 26 Fabius MRI Anesthesia Machines (Catalog Number 8607300) distributed to facilities in New York, Pennsylvania, and Wisconsin. The recall affects units including serial numbers ASPJ-0019, ASPJ-0020, ASPJ-0021, ASPK-0001, and ASPK-0002.
The recalled machines were manufactured with internal oxygen hoses incorrectly routed to the oxygen flush and oxygen flow control systems. This misrouting can cause the oxygen fresh gas flow to deviate from the clinician-set level when hospital oxygen central supply pressure is unstable.
If the oxygen flow deviation is not detected by medical staff, patients may receive insufficient oxygenation during anesthesia. No illnesses or injuries have been reported to date. Affected healthcare facilities should immediately contact Draeger Medical, Inc. for guidance on device inspection, repair, or replacement.
The recalled product
- Product
- Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300
- Manufacturer
- Draeger Medical, Inc.
- Hazard
- oxygen-routing-error
- hypoxia-risk
Distribution
Distributed nationwide across the United States.
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