C-RAD POSITIONING AB: Device Recall

Recall #Z-1858-2025 · 04/22/2025

Class II: Risk

Recall Details

Recall Number: Z-1858-2025
Classification: Class II
Product Type: Device
Recalling Firm: C-RAD POSITIONING AB
Status: Ongoing
Date Initiated: 04/22/2025
Location: Uppsala, N/A, Sweden
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 44 units

Reason for Recall

Software issue with scanning equipment that can results in the filed rotation not being applied correctly.

Product Description

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), Catalyst+ HD (SP003-0002), Catalyst+ PT (SP003-0008), Catalyst+ X4, (SPOO3-0009) Product Description: Patient positioning device, diagnostic imaging/radiotherapy, laser Component: Not a component

Distribution Pattern

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.

Other Recalls by C-RAD POSITIONING AB

Class II: Risk 10/09/2025

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.

View all recalls by C-RAD POSITIONING AB →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.