Philips Brilliance CT Big Bore X-Ray System Gantry Motion Collision Hazard

Plain-English summary

Philips North America LLC is recalling the Brilliance CT Big Bore, Software Version 4.8.0.10430 computed tomography X-ray system. The recall affects approximately 630 units distributed worldwide, including throughout the United States and numerous international markets.

The recalled devices have an unintended motion issue related to the interventional control that may lead to collision of the gantry or table with the operator or patient. No injuries or illnesses have been reported in the source material.

Facilities operating affected devices should contact Philips North America LLC for instructions on how to address this issue. The recall applies to Model numbers 728242, 728243, and 728244 with specific serial numbers and UDI codes listed in the FDA recall notice.

The recalled product

Product

Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.

Manufacturer

Philips North America Llc

Category

Medical Device — Computed Tomography / X-Ray System

Hazard

• collision
• unintended-motion

Affected units

630

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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