Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300
Check against the official notice below — it lists the full affected range.
Draeger Medical, Inc. is recalling five Draeger Fabius MRI Anesthesia machines (catalog number 8607300) distributed in New York, Pennsylvania, and Wisconsin. These machines were manufactured with internal oxygen hoses incorrectly routed, with the connections to the Oxygen Flush and Oxygen Flow Control switched. When hospital oxygen central supply pressure is unstable, this routing error could cause the oxygen fresh gas flow to deviate from the set value, potentially resulting in insufficient patient oxygenation if the deviation goes unnoticed.
The affected machines have the following serial numbers: ASPJ-0019, ASPJ-0020, ASPJ-0021, ASPK-0001, and ASPK-0002 (UDI 04048675041498). The recall source does not specify a remedy or actions consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: US Nationwide distribution in the states of NY, PA, and WI. Quantity: 5 Lot/code info: UDI 04048675041498 Serial Numbers ASPJ-0019 ASPJ-0020 ASPJ-0021 ASPK-0001 ASPK-0002
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.