Summary
The FDA issued a Class II for Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300 by Draeger Medical, Inc.. Reason: 26 Fabius MRI Anesthesia machines were distributed with internal hoses routing Oxygen to the Oxygen Flush and Oxygen Flow Control interchanged. If the.
Details
Source
Device Recall
External ID
Z-0501-2022
Action Date
2022-01-26
Status
Terminated
Category
device
Product Description
Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300
Lot/Code Info: UDI 04048675041498 Serial Numbers ASPJ-0019 ASPJ-0020 ASPJ-0021 ASPK-0001 ASPK-0002
Quantity Affected: 5
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-12-16
Company
Telford, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 107 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Draeger Medical, Inc. has 37 FDA actions in our database, including 37 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Draeger Medical, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Draeger Medical, Inc. have FDA actions?
Draeger Medical, Inc. has 37 FDA actions in our database, including 37 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0501-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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