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
Reported: June 4, 2025 Initiated: April 22, 2025 #Z-1858-2025
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.
Details
- Recalling Firm
- C-RAD POSITIONING AB
- Units Affected
- 44 units
- 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.
- Location
- Uppsala, N/A
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by C-RAD POSITIONING AB. Units affected: 44 units.
Why was this product recalled? ▼
Software issue with scanning equipment that can results in the filed rotation not being applied correctly.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 4, 2025. Severity: Moderate. Recall number: Z-1858-2025.
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