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Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300

FDA Recall #Z-0501-2022 — Class II — December 16, 2021

Recall #Z-0501-2022 Date: December 16, 2021 Classification: Class II Status: Terminated

Product Description

Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300

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.

Recalling Firm

Draeger Medical, Inc. — Telford, PA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

5

Distribution

US Nationwide distribution in the states of NY, PA, and WI.

Code Information

UDI 04048675041498 Serial Numbers ASPJ-0019 ASPJ-0020 ASPJ-0021 ASPK-0001 ASPK-0002

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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