The Recall Desk
SevereFDA (Devices)·Z-0544-2019·Announced 2018-12-12

Philips Brilliance 40 CT Systems Recalled for Gantry Cover Separation Risk

Philips is recalling 6,343 Brilliance 40 CT systems nationwide due to a potential fiberglass resin separation that could cause the gantry front cover to fall.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a structural defect in a medical device where a component (gantry cover) could fail and fall, posing a risk of significant injury, which aligns with the 'Severe' criteria for structural defects or significant injury reports.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 6,343 Brilliance 40 Computed Tomography (CT) X-ray systems, Model 728235. The recall is due to a potential for separation of fiberglass resin, which may cause the gantry front cover and the metal support on the cover to fail or fall.

The affected units were distributed nationwide in the United States. The source text does not specify the exact date of the recall or the specific serial numbers affected, though the structured data lists numerous system serial numbers.

Healthcare facilities should contact Philips Medical Systems for instructions on how to address the defect. The source text does not provide specific consumer instructions or a hotline number.

The recalled product

Product
Brilliance 40, Model 728235 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and displa
Manufacturer
Philips Medical Systems (Cleveland) Inc
Category
Medical Device — Imaging Equipment
Hazard
Affected units
6,343

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 recalled by Philips Medical Systems (Cleveland) Inc 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 6 products in this recall →

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