Aeos Robotic Digital Microscope software errors affect autofocus and rebalancing
Aesculap is recalling Aeos Robotic Digital Microscopes (versions 2.7 or earlier) due to application errors affecting rebalancing, recovery, and autofocus. Five units were distributed in Arkansas, Indiana, Nebraska, and North Carolina.
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 FDA Class II medical device recall involves software errors that could affect critical device functionality during clinical use. No illnesses or injuries have been reported, but the application errors affecting autofocus and rebalancing processes represent a potential risk of harm.
Plain-English summary
Aesculap Implant Systems LLC is recalling the Aeos Robotic Digital Microscope (Article Number PV010) with software versions 2.7 or earlier. This recall involves five units distributed across Arkansas, Indiana, Nebraska, and North Carolina.
The recall is due to application error problems affecting the device's rebalancing process, robot recovery functionality, and autofocus capability. The affected units are identified by serial numbers 1004, 1026, 1032, 1035, and 1036.
The FDA has classified this as a Class II recall.
The recalled product
- Product
- Aeos¿ Robotic Digital Microscope with software versions 2.7 or earlier Article Number: PV010
- Manufacturer
- Aesculap Implant Systems LLC
- Category
- Medical Device
- Affected units
- 5
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 (5)
- GUIDID: 04046955206742 Serial Numbers: 1004
- 1026
- 1032
- 1035
- 1036
Distribution
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