Aesculap Aeos Digital Microscope robotic arm malfunction requires system restart
Aesculap Implant Systems is recalling the UR5 robotic arm component in its Aeos Digital Microscope System due to malfunction that prevents arm movement and requires system restart.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm product (surgical robotic system component) where malfunction could affect procedure capability. No injuries or illnesses have been reported. FDA Class II classification and potential for operational impact during procedures support a High severity rating.
Plain-English summary
Aesculap Implant Systems LLC is recalling the Universal Robot UR5 arm (subcomponent PV010204) in the Aesculap Aeos Digital Microscope System. The robotic arm may malfunction, preventing further movement and requiring the entire digital microscope system to be restarted.
The affected product was distributed in the northeastern United States. The specific unit involved carries UDI-DI 04046955206742 with Serial Number SN1004.
Users who encounter this malfunction should stop using the affected unit and contact Aesculap Implant Systems LLC for guidance. Repeated malfunctions may indicate the need for professional service or unit replacement.
The recalled product
- Product
- Universal Robot UR5 arm, PV010204 subcomponent of Aesculap Aeos Digital Microscope System, PV010
- Manufacturer
- Aesculap Implant Systems LLC
- Hazard
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI: 04046955206742
- Serial Number: SN1004
Distribution
Distributed in 1 state:
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