FDA recall Z-0448-2024

Product

Monarch Platform REF MON-000005-01, 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

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.

Key facts

Status

Ongoing

Initiation date

2023-10-18

Report date

2023-12-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Redwood City, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0448-2024