Aeos Robotic Digital Microscope recalled for safety mechanism failure
Aesculap Inc is recalling Aeos Robotic Digital Microscope models with Product Code PV010 due to failure of the integrated safety mechanism. The robotic arm may drop more than 10 cm from its original position after the emergency stop button is pressed.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall addressing a risk-of-harm situation where injury has not been reported. The source describes a potential hazard—the robotic arm may drop due to safety mechanism failure—but does not document any cases of illness or injury.
Plain-English summary
Aesculap Inc is recalling the Aeos Robotic Digital Microscope, Product Code PV010. The recall affects 19 units distributed in Arkansas, Florida, Illinois, Indiana, Kentucky, Michigan, North Carolina, Nebraska, Oklahoma, South Dakota, and Texas.
The integrated safety mechanism of the affected microscopes may fail, allowing the robotic arm to drop more than 10 centimeters from its original position when the emergency stop button is pressed. This poses a potential hazard to users.
Individuals or organizations that have received Aeos Robotic Digital Microscope units with Product Code PV010 and Serial Numbers 1011, 1005, 1057, 1032, 1038, 1054, 1036, 1060, 1056, 1089, 1093, 1027, 1061, 1004, 1026, 1035, 1097, 1084, or 1063 should immediately stop using the affected devices.
Consumers should contact Aesculap Inc for instructions regarding return or replacement of the affected devices.
The recalled product
- Product
- Aeos Robotic Digital Microscope, Product Code: PV010
- Manufacturer
- Aesculap Inc
- Category
- Medical Device
- Affected units
- 19
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
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