Aeos¿ Robotic Digital Microscope with software versions 2.7 or earlier Article Number: PV010
Summary
The FDA issued a Class II for Aeos¿ Robotic Digital Microscope with software versions 2.7 or earlier Article by Aesculap Implant Systems LLC. Reason: Application error problems: Rebalance scope message: 1.Rebalancing process 2.Usage of Robot Recovery: 3. Autofocus not available:.
Details
Source
Device Recall
External ID
Z-1516-2022
Action Date
2022-08-17
Status
Terminated
Category
device
Product Description
Aeos¿ Robotic Digital Microscope with software versions 2.7 or earlier Article Number: PV010
Lot/Code Info: GUIDID: 04046955206742 Serial Numbers: 1004; 1026; 1032; 1035; 1036
Quantity Affected: 5 units
Reason for Recall
Application error problems: Rebalance scope message: 1.Rebalancing process 2.Usage of Robot Recovery: 3. Autofocus not available:
Distribution
US Distribution to states of: AR, IN, NE and NC
Type: Voluntary: Firm initiated
Recall Initiated: 2022-07-14
Company
Center Valley, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 96 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Aesculap Implant Systems LLC has 34 FDA actions in our database, including 33 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Aesculap Implant Systems LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Aesculap Implant Systems LLC have FDA actions?
Aesculap Implant Systems LLC has 34 FDA actions in our database, including 33 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1516-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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