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Aeos Robotic Digital Microscope with software versions 2.7… recallZ-1516-2022 · Aesculap Implant Systems LLC · initiated Jul 14, 2022

Class II Terminated

Is my device affected?

  1. 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.
  2. 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.
  3. 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

Application error problems: Rebalance scope message: 1.Rebalancing process 2.Usage of Robot Recovery: 3. Autofocus not available:

FDA root cause category: Software design

What the company is doing

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 [email protected], 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 [email protected] or by calling 1-833-425-1464.

Recall details

Recall number
Z-1516-2022
Recall class
Class II
Status
Terminated
Initiated by the company
Jul 14, 2022
Recalling firm
Aesculap Implant Systems LLC
Quantity
5 units
Product code
FSO
Distribution
US Distribution to states of: AR, IN, NE and NC

Product description

Aeos Robotic Digital Microscope with software versions 2.7 or earlier Article Number: PV010

Code information (models, lots, serial numbers)

GUIDID: 04046955206742 Serial Numbers: 1004; 1026; 1032; 1035; 1036

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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