FDAFDA · Food and drugs·Recall number Z-0450-2024
Monarch Platform REF MON-000006 100-240V- 50/60Hz 1440w
Published December 13, 2023 · Recall initiated: October 18, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- AURIS HEALTH INC
- Distributor
- 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.
- Lot
- Software version 2.2.4
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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