Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300
Recall
- Recall Number
- Z-0501-2022
- Event Number
- 89243
- Firm
- Draeger Medical, Inc.
- FEI Number
- 2517967
- Product Code
- BSZ
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- December 16, 2021
- Terminated
- April 17, 2023
- Address
- 3135 Quarry Rd, Telford, PA, 18969-1042
Description
Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300
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.
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).
US Nationwide distribution in the states of NY, PA, and WI.
5