Draeger Fabius MRI Anesthesia Machine recall
Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300
Why was Draeger Fabius MRI Anesthesia Machine recalled?
26 Fabius MRI Anesthesia machines were distributed with internal hoses routing Oxygen to the Oxygen Flush and Oxygen Flow Control interchanged. If the hospital O2 Central supply pressure is not stable, the O2 fresh gas flow could deviate from the adjusted value. If the deviation is not noticed, insufficient oxygenation of the patient may occur.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI 04048675041498 Serial Numbers ASPJ-0019 ASPJ-0020 ASPJ-0021 ASPK-0001 ASPK-0002
- Product
- Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300
- Recalling firm
- Draeger Medical, Inc.
- Quantity
- 5
- Distribution
- US Nationwide distribution in the states of NY, PA, and WI.
- Recall date
- January 26, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)