Reported Dec 13, 2023 · Ongoing
Monarch Platform REF MON-000006 100-240V- 50/60Hz 1440w
Auris Health Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: AURIS HEALTH INC · 150 Shoreline Dr · Redwood City, CA · 94065-1400
Is this the product you have?
- Monarch Platform REF MON-000006 100-240V- 50/60Hz 1440w
- Lot codes and dates
- Software version 2.2.4
- Amount recalled
- 110 units In total
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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