Z-1409-2022Class II

Universal Robot UR5 arm, PV010204 subcomponent of Aesculap Aeos Digital Microscope System, PV010

Name: Z-1409-2022 Universal Robot UR5 arm, PV010204 subcomponent of Aesculap Aeos Digital Microscope System, PV010
Creator: Aesculap Implant Systems LLC
Published: 2021-02-19
License: https://open.fda.gov/license/

Aesculap Inc / initiated 2021-02-19 / Completed / root cause: manufacturing process

FDA source

Aesculap Implant Systems LLC began a recall of Universal Robot UR5 arm, PV010204 subcomponent of Aesculap Aeos Digital Microscope System, PV010 on 2021-02-19. FDA classified it as Class II and gives the reason as "Malfunction of the robotic arm preventing further movement of the robotic arm and requiring restart of the robotic digital microscope system". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1409-2022
Classification: Class II
Status: Completed
Initiated: 2021-02-19
Posted: 2022-07-19
Recalling firm: Aesculap Inc
Product: Universal Robot UR5 arm, PV010204 subcomponent of Aesculap Aeos Digital Microscope System, PV010
Product code: FSO Microscope, Surgical, General & Plastic Surgery
Reason for recall: Malfunction of the robotic arm preventing further movement of the robotic arm and requiring restart of the robotic digital microscope system.
Root cause tag: manufacturing process
FDA 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 in commerce: 1
Distribution: United States: NE
Product codes and lots: UDI-DI: 04046955206742, Serial Number: SN1004

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1409-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1409-2022	Class II	Completed	Voluntary: Firm initiated	2022-07-27	2022-07-19

Product code FSO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)