The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0377-2026·Announced 2025-11-05

Brazil market CT scanner recalled over six software faults affecting movement

Philips Medical Systems is recalling one Incisive CT for Brazil SKD unit on software versions 5.1.0.X and 5.1.1.X over six software issues, including unintentional gantry and couch movement.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Scored 3 under the risk-of-harm criterion: uncommanded gantry movement and radiation delivered from the wrong orientation are hazards, and no injuries are reported.

Plain-English summary

The Philips Incisive CT for Brazil SKD, product code 728146, running software versions 5.1.0.X and 5.1.1.X, is being recalled over six identified issues. The record lists the quantity as 1 unit, outside the United States only, serial number 540000.

The firm describes: unintentional continued gantry or couch movement when a specific button series is used, requiring a manual stop; a Water Equivalent Diameter value that may set itself to zero during dose-modulated helical or axial scans, which may lead to an insufficient dose setting and noisy images; a software failure in which the ECG wave file is not saved, causing cardiac offline reconstruction to fail and the user to potentially rescan the patient; a fault in which patient orientation is changed to NULL under specific random scenarios, resulting in radiation delivered from the wrong orientation or position and producing incorrect and undiagnosable images; an inconsistent preview image display that skips images during scanning; and an auto ROI fault when mouse buttons are pressed together, which prevents the system from automatically triggering the subsequent clinical scan. Philips states there is a potential safety risk from additional tracker shots and/or rescanning a patient when the clinical scan is not triggered.

The FDA has classified the action as Class II. The enforcement record reports no injuries.

Sites running the affected software versions should follow Philips' instructions.

The recalled product

Product
Model: Incisive CT for Brazil SKD; Product Code (REF): 728146; Software Versions: 5.1.0.X & 5.1.1.X;
Manufacturer
PHILIPS MEDICAL SYSTEMS
Category
Medical Device — CT scanner
Hazard
Affected units
1

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)

  • Product Code (REF): 728146
  • UDI-DI: None
  • Serial Number: 540000

Distribution

Distributed in 18 states:

Part of a larger recall action

This product is one of 3 recalled by PHILIPS MEDICAL SYSTEMS under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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