Z-0450-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- December 13, 2023
- Initiation Date
- October 18, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 110 units In total
Product Description
Monarch Platform REF MON-000006 100-240V- 50/60Hz 1440w
Reason for Recall
Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view.
Distribution Pattern
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.
Code Information
Software version 2.2.4