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Recall Observatory FDA recall evidence

Device product

CORI REAL INTELLIGENCE Robotic Drill, Product No. ROB10013 and ROB10013S

Z-0708-2024

November 13, 2023

Class II

Product summary

Firm
Blue Belt Technologies, Inc
Event
Event 93620
Status
Ongoing
Classification
Class II
Quantity
1859 units
Official record key
device-enforcement:Z-0708-2024

Official wording

Reason: Possibility that the user is unable to resolve drill disconnection error messages.

Code information: UDI-DI: 00885556757321 and 00885556780886; Serial No. SN00001 through SN001202, SN500001 through SN502583.

Distribution pattern: Domestic: Nationwide Distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Possibility that the user is unable to resolve drill disconnection error messages.