FDA Medical Device Recalls (openFDA)
C-RAD POSITIONING AB: 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
- 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
- Status
- Terminated
- Initiated
- 2020-08-06
- Posted
- not on file
- Terminated
- 2022-04-15
- Reason
- PC Application Software c4D not changing Site upon synchronization during the Setup workflow step
- 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
- 7
- Distribution
- US Nationwide distribution in the states of IL, KY, MO and WA.
- Lot, serial or model codes
- Catalyst: SP-002, Software (part number): PA-003 version 6.1.1 and 6.1.0
- 510(k) numbers
- ["K113276"]
- PMA numbers
- not on file
- Product code
- IYE
- Firm FEI
- 3006621300
- Firm city
- Uppsala
- Firm state
- not on file
- Firm country
- Sweden
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28