Summary
The FDA issued a Class II for Monarch Platform REF MON-000005-01, 100-240V- 50/60Hz 1440w by AURIS HEALTH INC. Reason: Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view..
Details
Source
Device Recall
External ID
Z-0448-2024
Action Date
2023-12-13
Status
Ongoing
Category
device
Product Description
Monarch Platform REF MON-000005-01, 100-240V- 50/60Hz 1440w
Lot/Code Info: Software Version 2.2.4
Quantity Affected: 110 units In total
Reason for Recall
Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view.
Distribution
US Distribution: AK, AL, AZ, CA, CO, CT, DC, DE, FL, GA, IL, IN, KY, MA, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NY, OH, OR, PA, SC, SD, TN, TX, WI & WV.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-10-18
Company
Redwood City, CA
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 197 device recalls issued in the same week, part of 403 device-related FDA actions this month.
AURIS HEALTH INC has 10 FDA actions in our database, including 7 recalls and 3 clearances.
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 (AURIS HEALTH INC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does AURIS HEALTH INC have FDA actions?
AURIS HEALTH INC has 10 FDA actions in our database, including 7 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0448-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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