FDA recall Z-2139-2024

Aesculap Inc · Class II · device

Product

Aeos Robotic Digital Microscope, Product Code: PV010

Reason for recall

Possibility of the robotic arm to drop more than 10cm from its original position after pressing the emergency stop button due to failure of the integrated safety mechanism.

Distribution

US Nationwide distribution in the states of AR, FL, IL, IN, KY, MI, NC, NE, OK, SD, TX.

Key facts

Status
Ongoing
Initiation date
2024-05-13
Report date
2024-06-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2139-2024