Reported Jun 4, 2025 · Ongoing

Brand Name: Catalyst+ Product Name: C4D software used in conjunction with Catalyst (SP001-0025), Catalyst HD…

C-Rad Positioning Ab

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: C-RAD POSITIONING AB · Bredgrand 18 · Uppsala, N/A · N/A

Is this the product you have?

  • Brand NameCatalyst+
  • Product NameC4D 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 DescriptionPatient positioning device, diagnostic imaging/radiotherapy
  • laser ComponentNot a component
Lot codes and dates

5 of 5 products

Products covered by this recall
Model / numberBarcodesProduct as published
07350005280024c4D 6.5.1 SP2 Catalyst -SP001-0025/UDI: 07350005280024
07350005280024Catalyst HD- SP001-0026/UDI: 07350005280024
07350005280024Catalyst PT- SP001-0027/UDI: 07350005280024
07350005280024Catalyst X4- SP002-0035/UDI: 07350005280024
SP003-0001/UDI17350005280762173500052807791735000528079317350005280809Catalyst+ - : 17350005280762 Catalyst+ HD- SP003-0002/UDI: 17350005280779 Catalyst+ PT- SP003-0008/UDI: 17350005280793 Catalyst+ X4 - SP003-0009/UDI: 17350005280809
Amount recalled
44 units

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:57 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.