Recall Z-0708-2024— Blue Belt Technologies, Inc

Name: FDA recall Z-0708-2024
Creator: U.S. Food and Drug Administration
Published: 2023-11-13

Class II · Ongoing

Class II FDA medical device recall by Blue Belt Technologies, Inc, initiated 2023-11-13. It names one FDA 510(k) clearance: K231963. Product: CORI REAL INTELLIGENCE Robotic Drill, Product No. ROB10013 and ROB10013S. Reason: Possibility that the user is unable to resolve drill disconnection error messages..

Recalling firm: Blue Belt Technologies, Inc
Classification: Class II
Status: Ongoing
Initiated: 2023-11-13
Firm location: Pittsburgh, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K231963 — REAL INTELLIGENCE CORIBlue Belt Technologies, Inc.·cleared 2023-08-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.