Medical device recalls Moderate risk

Aesculap Implant Systems LLC recalls Aeos¿ Robotic Digital Microscope with software versions 2.7 or earlier Article Number: PV010

Recall date
July 14, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1516-2022
FDA classification
Class II
Brand / firm
Aesculap Implant Systems LLC
Sold / distributed
US Distribution to states of: AR, IN, NE and NC

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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