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Aeos Robotic Digital Microscope, Product Code: PV010 recallZ-2139-2024 · Aesculap Inc · initiated May 13, 2024

Open, Classified

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 Inc 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

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.

FDA root cause category: Process control

What the company is doing

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.

Recall details

Recall number
Z-2139-2024
Status
Open, Classified
Initiated by the company
May 13, 2024
Posted by the FDA
Jun 12, 2024
Recalling firm
Aesculap Inc
Quantity
19 units
Product code
FSO
Distribution
US Nationwide distribution in the states of AR, FL, IL, IN, KY, MI, NC, NE, OK, SD, TX.

Product description

Aeos Robotic Digital Microscope, Product Code: PV010

Code information (models, lots, serial numbers)

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

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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