FDA Medical Device Recalls (openFDA)
Aesculap Implant Systems LLC: Aeos Robotic Digital Microscope with software versions 2.7 or earlier Article Number: PV010
- Recall number
- Z-1516-2022
- Recalling firm
- Aesculap Implant Systems LLC
- Product
- Aeos Robotic Digital Microscope with software versions 2.7 or earlier Article Number: PV010
- Status
- Terminated
- Initiated
- 2022-07-14
- Posted
- not on file
- Terminated
- 2025-02-07
- Reason
- Application error problems: Rebalance scope message: 1.Rebalancing process 2.Usage of Robot Recovery: 3. Autofocus not available:
- Root cause
- Software design
- Action
- The firm, Aesculap Inc., issued "URGENT MEDICAL DEVICE CORRECTION" letter dated July 14, 2022. Letter states reason for recall, health risk and action to take: Address the application error concerns, the product instructions for use (IFU) have been updated and a new software version for the Aeos Robotic Digital Microscope (version 2.8.1.115) has been released. All customers are being provided the updated IFU and software. Refer to Actions Required by Aesculap Inc. Customer/User below. 1. Review the Device Correction Notification in its entirety and notify users and other relevant personnel within your organization. 2. Download the updated product IFU and ensure all users are aware of the updates. To obtain the updated IFU, please perform the following steps: a. Using your organizations approved web browser (e.g. Google Chrome, Microsoft Edge, etc.), enter the URL: https://www.aesculapusaifus.com. b. In the search field enter the Item Number: PV010 and press Search c. Click on the file AEOS Digital Microscope IFU (TA015615). Note: You will need a PDF viewer such as Adobe Acrobat to view the file. d. Print or distribute the IFU to relevant personnel. Maintain a copy in close proximity to the device for easy reference by the users. 3. Complete the Product Correction Acknowledgement form. If you have no inventory remaining, enter zero (0) on the form. 4. Return the completed Product Correction Acknowledgement form to our Quality Assurance department by e-mailing to qa-recalls@aesculapusa.com, even if the total inventory in your possession is zero (0). 5. Once we have received your acknowledgement form an Aesculap representative will contact you to arrange for qualified Aesculap personnel to update the software on your device. Report any concerns or issues to our Postmarket Surveillance team by contacting ProductQualityExcellence@bbraunusa.com or by calling 1-833-425-1464.
- Quantity
- 5 units
- Distribution
- US Distribution to states of: AR, IN, NE and NC
- Lot, serial or model codes
- GUIDID: 04046955206742 Serial Numbers: 1004; 1026; 1032; 1035; 1036
- 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