Uppsala, Sweden
C-RAD POSITIONING AB recalls
3 recalls recorded since 2018, most recently on 9 October 2025. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)2
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 9 October 2025
- Reason
- Due to issues with the system's stereotactic radiosurgery (SRS) treatment cannot be guaranteed for all couch angles and system setups. n certain cases, the system may indicate the patient as correctly positioned at the isocenter, even when the isocenter is positioned outside of the indicated tolerance.
- Distribution
- The software module cSRS has been installed in 37 countries Worldwide - U.S. Nationwide distribution in the states of AK, AL, AR, CA, CT, FL, MO, NC, NM, NY, OH, OK, OR, PA, TN, TX, VA, and WA. The countries of Argentina, Australia, Austria, Belarus, Belgium, Benin, Canada, China, Colombia, Egypt,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1092-2026
- Brand 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 positioni
Ongoing Class II Medical devices
- Recall started
- 22 April 2025
- Reason
- Software issue with scanning equipment that can results in the filed rotation not being applied correctly.
- Distribution
- Worldwide - US Nationwide distribution in the states of AK, FL, WA, VA, WA, NC, IL, AR, NC and the countries of Germany, Italy, Uzbekistan, South Korea, Vietnam, Austria, Australia, China, Estonia, Belgium, Uzbekistan.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1858-2025
- Brand 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), Catal
Terminated Class II Medical devices
- Recall started
- 6 August 2020
- Terminated
- 15 April 2022
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.