Food, drugs, devices › C-RAD POSITIONING AB
Device recall: PC Application Software c4D as part of the device Catalyst: SP-002 Software PA-003 version 6.1.1 and 6.1.0
FDA enforcement event 88084 is a device recall by C-RAD POSITIONING AB of Uppsala, initiated 6 Aug 2020 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 916 device enforcement events initiated in 2020 carry the same class.
Status: Terminated, terminated 15 Apr 2022. Initiation: voluntary: firm initiated. C-RAD POSITIONING AB has 3 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
C-RAD POSITIONING AB, Uppsala, Sweden.
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."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| 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 | 7 | Class II | Terminated | 21 Jul 2021 |
Context
Other enforcement events for C-RAD POSITIONING AB
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 9 Oct 2025 | Brand Name: Catalyst+ Product Name: Catalyst, Catalyst+ Model/Catalog Number: SP001-0026, SP003-0002 Software Version: c | Device | Class II | 1 |
| 22 Apr 2025 | Brand Name: Catalyst+ Product Name: C4D software used in conjunction with Catalyst (SP001-0025), Catalyst HD (SP001-0026 | Device | Class II | 1 |
All 3 events for C-RAD POSITIONING AB
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "PC Application Software c4D not changing Site upon synchronization during the Setup workflow step"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide distribution in the states of IL, KY, MO and WA."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 15 Apr 2022. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.