Recall Register

Food, drugs, devices › Firms

C-RAD POSITIONING AB

FDA recalling firm · 3 enforcement events · 3 product records · 2020–2025 · N/A

C-RAD POSITIONING AB has 3 FDA enforcement events on this register (3 product records) between 2020 and 2025: 3 device; the busiest year was 2025 with 2.

0% of its events are Class I; the most common class is Class II (3). 2 events are listed as ongoing; the recalling firm's address is in N/A.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
9 Oct 2025Brand Name: Catalyst+ Product Name: Catalyst, Catalyst+ Model/Catalog Number: SP001-0026, SP003-0002 Software Version: cSRS module in combination with cMotion module Product Description: GMDN: 40893 Patient positioning device, diagnostic imaging/radiotherapy, laser Component: Not applicableDeviceClass II1Ongoing
22 Apr 2025Brand Name: Catalyst+ Product Name: C4D software used in conjunction with Catalyst (SP001-0025), Catalyst HD (SP001-0026), Catalyst PT (SP001-0027), Catalyst X4 (SP002-0035), Catalyst+ (SP003-0001), Catalyst+ HD (SP003-0002), Catalyst+ PT (SP003-0008), Catalyst+ X4, (SPOO3-0009) Product Description: Patient…DeviceClass II1Ongoing
6 Aug 2020PC Application Software c4D as part of the device Catalyst: SP-002 Software PA-003 version 6.1.1 and 6.1.0DeviceClass II1Terminated

By type and class

Device3
Class II3

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

20
21
22
23
24
25
26
Enforcement events for C-RAD POSITIONING AB by year initiated.

Questions and answers

How many FDA recalls has C-RAD POSITIONING AB had?

3 enforcement events (3 product records) on this register, 2020–2025: 3 device.

Are any C-RAD POSITIONING AB recalls ongoing?

2 events are listed as ongoing in the current openFDA export.

What class are C-RAD POSITIONING AB recalls?

3 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.