Recall Z-0501-2022 ยท BSZ Gas-Machine, Anesthesia
Draeger Medical, Inc.
Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300
| Date | Dec 16, 2021 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process control |
| Action | 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 |
| Quantity | 5 |
| Distribution | US Nationwide distribution in the states of NY, PA, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072884 | FABIUS MRI Draeger Medical AG & Co. KG, Jul 30, 2008 |