Draeger Fabius MRI Anesthesia Machine, Catalog Number… recallZ-0501-2022 · Draeger Medical, Inc. · initiated Dec 16, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Draeger Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Process control
What the company is doing
On December 17, 2021, the firm notified customers via Urgent Medical Device Correction Notice. Customers were instructed to do the following: Please ensure that all users of the above-mentioned products and other concerned persons within your organization are made aware of this Urgent Medical Device Correction Notice. If you have provided the products to third parties, please forward a copy of this information. Please keep this information at least until the corrective measure has been completed. Please also complete and return the attached Customer Acknowledgment Card to confirm to us that you have received this information. A Drger Service representative will contact you to arrange a date for the correction to be performed free of charge. Until the repair has been concluded you may continue using the device under constant supervision as long as appropriate O2-monitoring is in place and a suitable alarm limit is set. Please consider a suitable buffer when adjusting the O2 flow. If you have any questions regarding the operation of your Fabius MRI Anesthesia Machine, please contact Drger Service Technical Support between the hours of 8:00 AM 8:00 PM EST at 1-800-437- 2437 (press 2 at the prompt, then 2, then 2 again). If you have any questions regarding this recall communication, please contact Michael Kelhart between the hours of 8:00 AM 4:30 PM EST at 1-800-437-2437 (press 1 at the prompt, then 32349).
Recall details
- Recall number
- Z-0501-2022
- Status
- Terminated
- Initiated by the company
- Dec 16, 2021
- Recalling firm
- Draeger Medical, Inc.
- Quantity
- 5
- Product code
- BSZ
- FDA submissions
- K072884
- Distribution
- US Nationwide distribution in the states of NY, PA, and WI.
Product description
Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300
Code information (models, lots, serial numbers)
UDI 04048675041498 Serial Numbers ASPJ-0019 ASPJ-0020 ASPJ-0021 ASPK-0001 ASPK-0002
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Fabius MRI 8607300Drägerwerk AG & Co. KGaA · Gas-Machine, Anesthesia1 recall19 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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