Z-1858-2025 Class II Ongoing
FDA device recall Z-1858-2025 was initiated by C-RAD POSITIONING AB on April 22, 2025 and is designated Class II. Reason for recall: Software issue with scanning equipment that can results in the filed rotation not being applied correctly. The recall status is ongoing. Affected quantity: 44 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 4, 2025
- Initiation Date
- April 22, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 44 units
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
Reason for Recall
Software issue with scanning equipment that can results in the filed rotation not being applied correctly.
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.
Code Information
All Catalyst products using software Version: c4D 6.5.1 SP2 Catalyst -SP001-0025/UDI: 07350005280024; Catalyst HD- SP001-0026/UDI: 07350005280024; Catalyst PT- SP001-0027/UDI: 07350005280024; Catalyst X4- SP002-0035/UDI: 07350005280024; Catalyst+ - REF: SP003-0001/UDI: 17350005280762 Catalyst+ HD- SP003-0002/UDI: 17350005280779 Catalyst+ PT- SP003-0008/UDI: 17350005280793 Catalyst+ X4 - SP003-0009/UDI: 17350005280809