Z-2139-2024Class II

Aeos Robotic Digital Microscope

Name: Z-2139-2024 Aeos Robotic Digital Microscope
Creator: Aesculap Inc
Published: 2024-05-13
License: https://open.fda.gov/license/

Aesculap Inc / initiated 2024-05-13 / Open, Classified / root cause: manufacturing process

FDA source

Aesculap Inc began a recall of Aeos Robotic Digital Microscope, Product Code: PV010 on 2024-05-13. FDA classified it as Class II and gives the reason as "Possibility of the robotic arm to drop more than 10cm from its original position after pressing the emergency stop button due to failure of the integrated safety mechanism". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2139-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-05-13
Posted: 2024-06-12
Recalling firm: Aesculap Inc
Product: Aeos Robotic Digital Microscope, Product Code: PV010
Product code: FSO Microscope, Surgical, General & Plastic Surgery
Reason for recall: Possibility of the robotic arm to drop more than 10cm from its original position after pressing the emergency stop button due to failure of the integrated safety mechanism.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On May 13, 2024, URGENT MEDICAL DEVICE FIELD CORRECTION letters were mailed to customers. Actions to be taken by the customer: 1. Review the Device Correction Notification in its entirety and ensure that all users in your organization of the device and other concerned persons are informed about this voluntary product correction. If you are a distributor, please forward this correction notification to your customers. The correction is to be extended to the end user/customer level. 2. Determine your current inventory of the affected material within your facility, cease use and quarantine product subject to correction. Do not destroy any affected product. (Once your completed Urgent Medical Device Form is received, a representative will be in contact to arrange for inspection and testing). 3. Utilizing the attached "Urgent Medical Device Correction Acknowledgement Form," record the total number of individual units in your posession. If you have no inventory, please enter zero (0) on the form. 4. Return the completed "Urgent Medical Device Correction Acknowledgement Form" to the Aesculap Inc. Quality Assurance Department by faxing the form to (610)849-1197 or e-mail to [email protected] within two (2) weeks of receipt, even if the total inventory in your possession is zero (0). 5. Once we receive your acknowledgement Form, an Aesculap representative will contact you to arrange inspection and testing of your devices by our authorized specialists. Should you identify a problem or safety concern with the product, please report promptly by contacting our Post-market Surveillance Department at 1-833-425-1464. Additionally, adverse reactions of quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting Program wither online, by regular mail or fax.
Quantity in commerce: 19 units
Distribution: US Nationwide distribution in the states of AR, FL, IL, IN, KY, MI, NC, NE, OK, SD, TX.
Product codes and lots: Product Code: PV010, UDI/DI: 04046955206742; Serial Numbers: 1011, 1005, 1057, 1032, 1038, 1054, 1036, 1060, 1056, 1089, 1093, 1027, 1061, 1004, 1026, 1035, 1097, 1084, 1063

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2139-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2139-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-19	2024-06-12

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)