CORI REAL INTELLIGENCE Robotic Drill, Product No. ROB10013 and ROB10013S
Summary
The FDA issued a Class II for CORI REAL INTELLIGENCE Robotic Drill, Product No. ROB10013 and ROB10013S by Blue Belt Technologies, Inc. Reason: Possibility that the user is unable to resolve drill disconnection error messages..
Details
Source
Device Recall
External ID
Z-0708-2024
Action Date
2024-01-17
Status
Ongoing
Category
device
Product Description
CORI REAL INTELLIGENCE Robotic Drill, Product No. ROB10013 and ROB10013S
Lot/Code Info: UDI-DI: 00885556757321 and 00885556780886; Serial No. SN00001 through SN001202, SN500001 through SN502583.
Quantity Affected: 1859 units
Reason for Recall
Possibility that the user is unable to resolve drill disconnection error messages.
Distribution
Domestic: Nationwide Distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-11-13
Company
Pittsburgh, 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 158 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Blue Belt Technologies, Inc has 14 FDA actions in our database, including 3 recalls and 11 clearances.
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 (Blue Belt Technologies, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Blue Belt Technologies, Inc have FDA actions?
Blue Belt Technologies, Inc has 14 FDA actions in our database, including 3 recalls and 11 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0708-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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