FDA Device recall Z-1858-2025
Brand Name: Catalyst+ Product Name: C4D software used in conjunction with Catalyst (SP001-0025), Catalyst HD (SP001-0026), Catalyst PT (SP0…
- FDA Device
- Class II
- ongoing
- Published 2025-06-04
On 2025-06-04 the FDA classified a Class II recall of Brand Name: Catalyst+ Product Name: C4D software used in conjunction with Catalyst (SP001-0025), Catalyst HD (SP001-0026), Catalyst PT (SP0… by C Rad Positioning Ab, citing software issue with scanning equipment that can results in the filed rotation not being applied correctly.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1858-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-04-22 |
| Published | 2025-06-04 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | C Rad Positioning Ab |
| Distribution | US |
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.
Identifiers
| code_info | All Catalyst products using software Version: c4D 6.5.1 SP2 Catalyst -SP001-0025/UDI: 07350005280024; Catalyst HD- SP0…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1858-2025%22
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