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Recall Observatory FDA recall evidence

Device product

PC Application Software c4D as part of the device Catalyst: SP-002 Software PA-003 version 6.1.1 and 6.1.0

Z-2075-2021

August 06, 2020

Class II

Product summary

Firm
C-RAD POSITIONING AB
Event
Event 88084
Status
Terminated
Classification
Class II
Quantity
7
Official record key
device-enforcement:Z-2075-2021

Official wording

Reason: PC Application Software c4D not changing Site upon synchronization during the Setup workflow step

Code information: Catalyst: SP-002, Software (part number): PA-003 version 6.1.1 and 6.1.0

Distribution pattern: US Nationwide distribution in the states of IL, KY, MO and WA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    PC Application Software c4D not changing Site upon synchronization during the Setup workflow step