Agency classClass IIOur severity:High FDA (Devices)·Z-1660-2025·Announced 2025-04-30

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

Philips is recalling Brilliance CT Big Bore computed tomography systems due to unintended motion in the interventional control that may cause the gantry or table to collide with operators or patients.

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: This is an FDA Class II recall involving a medical device with a risk-of-harm hazard (collision with operator or patient). The source text does not report any injuries or illnesses, but the potential for unintended motion creating a collision hazard qualifies as a high-risk condition per the rubric.

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.

Lot numbers (20)

Model No. 728242
728243
728244
UDI: (01)00884838098725(21)7014
(01)00884838098725(21)7032
(01)00884838059450(21)7056
(01)00884838098725(21)7060
(01)00884838098725(21)7062
(01)00884838098725(21)7064
(01)00884838098725(21)7072
(01)00884838098725(21)7087
(01)00884838059450(21)7096
(01)00884838059450(21)7123
(01)00884838059450(21)7124
(01)00884838098725(21)7128
(01)00884838098725(21)7135
(01)00884838098725(21)7154
(01)00884838098725(21)7163
(01)00884838098725(21)7179
(01)00884838098725(21)7191

Distribution

Distributed nationwide across the United States.

Same manufacturer · Philips North America Llc

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Same hazard · collision