FDA Medical Device Recalls (openFDA)
Aesculap Implant Systems LLC: Universal Robot UR5 arm, PV010204 subcomponent of Aesculap Aeos Digital Microscope System, PV010
- Recall number
- Z-1409-2022
- Recalling firm
- Aesculap Implant Systems LLC
- Product
- Universal Robot UR5 arm, PV010204 subcomponent of Aesculap Aeos Digital Microscope System, PV010
- Status
- Completed
- Initiated
- 2021-02-19
- Posted
- not on file
- Terminated
- not on file
- Reason
- Malfunction of the robotic arm preventing further movement of the robotic arm and requiring restart of the robotic digital microscope system.
- Root cause
- Material/Component Contamination
- Action
- 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.
- Quantity
- 1
- Distribution
- United States: NE
- Lot, serial or model codes
- UDI-DI: 04046955206742, Serial Number: SN1004
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FSO
- Firm FEI
- 2916714
- Firm city
- Center Valley
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28