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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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High RiskFDA Device
Medical Devices/Surgical Equipment

Aesculap Inc: Aeos Robotic Digital Microscope Recalled Due to Risk of Robotic Arm Dropping

Agency Publication Date: June 12, 2024
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Summary

Aesculap Inc. is recalling 19 units of the Aeos Robotic Digital Microscope (Product Code PV010) because a safety mechanism can fail. When the emergency stop button is pressed, the robotic arm may drop more than 10 centimeters from its original position instead of locking securely in place. This recall affects specific serial numbers of the device distributed across 11 states in the U.S.

Risk

If the robotic arm drops unexpectedly during a medical procedure, it could strike a patient or medical staff, potentially causing serious physical injury or disrupting a delicate surgical operation.

What You Should Do

  1. Check your device's serial number to see if it is one of the 19 affected units: 1011, 1005, 1057, 1032, 1038, 1054, 1036, 1060, 1056, 1089, 1093, 1027, 1061, 1004, 1026, 1035, 1097, 1084, or 1063.
  2. Identify the product by looking for Product Code PV010 and UDI/DI 04046955206742 on the device labeling.
  3. Contact your healthcare facility's equipment manager or Aesculap Inc. immediately to discuss the safety of the device and any necessary inspections or repairs.
  4. If you are a healthcare provider, contact Aesculap Inc. at their Center Valley, PA office for further instructions regarding the integrated safety mechanism failure.
  5. For additional questions or to report a problem, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Contact Manufacturer for Instructions

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Aeos Robotic Digital Microscope
Model / REF:
PV010
UPC Codes:
04046955206742
Lot Numbers:
Serial Numbers: 1011, 1005, 1057, 1032, 1038, 1054, 1036, 1060, 1056, 1089, 1093, 1027, 1061, 1004, 1026, 1035, 1097, 1084, 1063

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94623
Status: Active
Manufacturer: Aesculap Inc
Sold By: Aesculap Inc; Medical facilities
Manufactured In: United States
Units Affected: 19 units
Distributed To: Arkansas, Florida, Illinois, Indiana, Kentucky, Michigan, North Carolina, Nebraska, Oklahoma, South Dakota, Texas

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.