Z-2075-2021Class II

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

Name: Z-2075-2021 PC Application Software c4D as part of the device Catalyst: SP-002 Software PA-003 version 6.1.1 and 6.1.0
Creator: C-Rad Positioning Ab
Published: 2020-08-06
License: https://open.fda.gov/license/

C-Rad Positioning AB / initiated 2020-08-06 / Terminated / root cause: software

FDA source

C-RAD POSITIONING AB began a recall of PC Application Software c4D as part of the device Catalyst: SP-002 Software PA-003 version 6.1.1 and 6.1.0 on 2020-08-06. FDA classified it as Class II and gives the reason as "PC Application Software c4D not changing Site upon synchronization during the Setup workflow step". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2075-2021
Classification: Class II
Status: Terminated
Initiated: 2020-08-06
Posted: 2021-07-14
Terminated: 2022-04-15
Recalling firm: C-Rad Positioning AB
Product: PC Application Software c4D as part of the device Catalyst: SP-002 Software PA-003 version 6.1.1 and 6.1.0
Product code: IYE Accelerator, Linear, Medical
Reason for recall: PC Application Software c4D not changing Site upon synchronization during the Setup workflow step
Root cause tag: software
FDA root cause: Component change control
Action: On August 11, 2020, an e-mail letter containing PA-003-200806-001-01, c4D not changing Site upon synchronization during the Setup workflow step (attached) has been sent personally to our contact persons at the affected sites. In a second step C-RAD upgraded the software at all affected sites to bring back the system to the originally intended state..
Quantity in commerce: 7
Distribution: US Nationwide distribution in the states of IL, KY, MO and WA.
Product codes and lots: Catalyst: SP-002, Software (part number): PA-003 version 6.1.1 and 6.1.0

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2075-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2075-2021	Class II	Terminated	Voluntary: Firm initiated	2021-07-21	2021-07-14

Product code IYE

K113276Class IICatalystC-Rad Positioning AB / cleared 2012-02-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)