FDA recall Z-1516-2022

Aesculap Implant Systems LLC · Class II · device

Product

Aeos¿ Robotic Digital Microscope with software versions 2.7 or earlier Article Number: PV010

Reason for recall

Application error problems: Rebalance scope message: 1.Rebalancing process 2.Usage of Robot Recovery: 3. Autofocus not available:

Distribution

US Distribution to states of: AR, IN, NE and NC

Key facts

Status
Terminated
Initiation date
2022-07-14
Report date
2022-08-17
Termination date
2025-02-07
Voluntary/Mandated
Voluntary: Firm initiated
Location
Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1516-2022