FDAClass IIJuly 21, 2021

PC Application Software c4D as recall: Software Issue

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

Why was PC Application Software c4D as recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
PC Application Software c4D as part of the device Catalyst: SP-002 Software PA-003 version 6.1.1 and 6.1.0
Recalling firm
C-RAD POSITIONING AB
Quantity
7
Distribution
US Nationwide distribution in the states of IL, KY, MO and WA.
Recall date
July 21, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls