The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1858-2025·Announced 2025-06-04

Catalyst+ Patient Positioning Software May Fail to Apply Rotation Correctly

C-RAD POSITIONING AB has recalled Catalyst+ and related patient positioning devices due to a software issue where field rotation may not be applied correctly during scanning.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall. The source text describes a software malfunction with no reported illnesses or injuries, making it a precautionary/minor functional defect rather than a high-risk hazard scenario.

Plain-English summary

C-RAD POSITIONING AB is recalling Catalyst+ C4D software used with multiple Catalyst patient positioning devices (Catalyst, Catalyst HD, Catalyst PT, Catalyst X4, Catalyst+, Catalyst+ HD, Catalyst+ PT, and Catalyst+ X4) due to a software issue that can result in field rotation not being applied correctly.

The recalled devices are used for patient positioning in diagnostic imaging and radiotherapy. All units running software Version c4D 6.5.1 SP2 are affected. Affected equipment has been distributed worldwide, including to facilities in Alaska, Florida, Washington, Virginia, North Carolina, Illinois, Arkansas, and internationally to Germany, Italy, Uzbekistan, South Korea, Vietnam, Austria, Australia, China, Estonia, and Belgium. A total of 44 units are involved in this recall.

Patients and healthcare providers using affected Catalyst+ positioning equipment should contact C-RAD POSITIONING AB for instructions on obtaining a software update or other corrective measures. The manufacturer holds the recall responsibility for addressing this issue.

The recalled product

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)…
Manufacturer
C-RAD POSITIONING AB
Category
Medical Device — Patient Positioning / Diagnostic Imaging
Hazard
Affected units
44

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Catalyst HD- SP001-0026/UDI: 07350005280024
  • Catalyst PT- SP001-0027/UDI: 07350005280024
  • Catalyst X4- SP002-0035/UDI: 07350005280024

Distribution

Distributed nationwide across the United States.

The notice also names 7 states specifically:

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