Brazil market CT scanner recalled over six software faults affecting movement

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

• software-defect
• uncommanded-movement
• radiation-dose
• erroneous-images

Is your product affected?

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

Distribution

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