Philips Inclusive CT Systems: Software Errors in Image Display and Interpretation

Plain-English summary

Philips North America Llc is recalling 330 Philips Inclusive CT imaging systems worldwide. The Philips Inclusive CT is a whole-body computed tomography x-ray system that reconstructs x-ray transmission data into cross-sectional images of the body.

The recall addresses three software issues: incorrect image display, errors in interpreting patient images during the image reporting process, and patient exposure to incorrect images or system functions during clinical use. These defects may affect the diagnostic accuracy of imaging information provided to clinicians.

Affected systems were distributed domestically across multiple U.S. states and internationally to numerous countries. This is an FDA Class II recall.

The recalled product

Product

The device is a whole-body CT x-ray system. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. The system also includes signal analysis and display equipment, patient and equipment suppor

Manufacturer

Philips North America Llc

Category

Medical Device — Diagnostic Imaging

Hazard

• image-display-error
• image-interpretation-error

Affected units

330

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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