PC Application Software c4D as part of the device Catalyst: SP-002 Software PA-003 version 6.1.1 and 6.1.0
Summary
The FDA issued a Class II for PC Application Software c4D as part of the device Catalyst: SP-002 Software PA-0 by C-RAD POSITIONING AB. Reason: PC Application Software c4D not changing Site upon synchronization during the Setup workflow step.
Details
Source
Device Recall
External ID
Z-2075-2021
Action Date
2021-07-21
Status
Terminated
Category
device
Product Description
PC Application Software c4D as part of the device Catalyst: SP-002 Software PA-003 version 6.1.1 and 6.1.0
Lot/Code Info: Catalyst: SP-002, Software (part number): PA-003 version 6.1.1 and 6.1.0
Quantity Affected: 7
Reason for Recall
PC Application Software c4D not changing Site upon synchronization during the Setup workflow step
Distribution
US Nationwide distribution in the states of IL, KY, MO and WA.
Type: Voluntary: Firm initiated
Recall Initiated: 2020-08-06
Company
Uppsala
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 157 device recalls issued in the same week, part of 403 device-related FDA actions this month.
C-RAD POSITIONING AB has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (C-RAD POSITIONING AB) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does C-RAD POSITIONING AB have FDA actions?
C-RAD POSITIONING AB has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2075-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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