Recall Z-1858-2025— C-RAD POSITIONING AB
Class II · Ongoing
Class II FDA medical device recall by C-RAD POSITIONING AB, initiated 2025-04-22. It names one FDA 510(k) clearance: K200435. Product: 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: Software issue with scanning equipment that can results in the filed rotation not being applied correctly..
- Recalling firm
- C-RAD POSITIONING AB
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-04-22
- Firm location
- Uppsala, N/A, Sweden
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.