Universal Robot UR5 arm, PV010204 subcomponent of Aesculap… recallZ-1409-2022 · Aesculap Implant Systems LLC · initiated Feb 19, 2021
Completed
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Aesculap Implant Systems LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Malfunction of the robotic arm preventing further movement of the robotic arm and requiring restart of the robotic digital microscope system.
FDA root cause category: Material/Component Contamination
What the company is doing
An Urgent Market Withdrawal Notification letter issued February 19, 2021 was mailed USPS certified. The letter identifies the Universal Robot UR5 arm as part of hte Aesculap Aeos System and requests the customer return the acknowledgement form and schedule repair by service technician.
Recall details
- Recall number
- Z-1409-2022
- Status
- Completed
- Initiated by the company
- Feb 19, 2021
- Recalling firm
- Aesculap Implant Systems LLC
- Quantity
- 1
- Product code
- FSO
- Distribution
- United States: NE
Product description
Universal Robot UR5 arm, PV010204 subcomponent of Aesculap Aeos Digital Microscope System, PV010
Code information (models, lots, serial numbers)
UDI-DI: 04046955206742, Serial Number: SN1004
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- AESCULAP PV010Aesculap AG · MICROSCOPE, SURGICAL, GENERAL & PLASTIC SURGERY3 recalls8 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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