Company: C-RAD POSITIONING AB
Date of Enforcement Report: 7/21/2021
Class II
PRODUCT
PC Application Software c4D as part of the device Catalyst: SP-002 Software PA-003 version 6.1.1 and 6.1.0
Recall Number: Z-2075-2021
REASON
PC Application Software c4D not changing site upon synchronization during the setup workflow step.
RECALLING FIRM/MANUFACTURER
C-RAD POSITIONING AB on 8/6/2020. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
7
DISTRIBUTION
U.S. Nationwide