Brilliance iCT recallZ-0391-2018 · Philips Medical Systems (Cleveland) Inc · initiated Nov 10, 2017

Terminated

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Philips Medical Systems (Cleveland) Inc or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Philips has identified that certain fasteners cannot be confirmed to have been torqued according to specification. If the fasteners were not torqued as specified and a failure occurs while the system is in use, the parts secured by the fasteners may become loose, which may have a potential for harm.

FDA root cause category: Under Investigation by firm

What the company is doing

An Urgent - Field Safety Notice Medical Device Correction letter, dated November 1, 2017, was sent to customers. The letter identified the affected device, described the issue, and discussed the hazard involved. Users are to cease use immediately and contact their Philips Field Service Engineer, if any unusual noises are heard within the gantry, or if the patient support tabletop is in free float. Philips Field Service Engineers will correct the system by replacing the affected fasteners. If further info or support concerning this issue is needed, customers can contact their local Philips rep or the Customer Care Solutions Center at 1-800-722-9377.

Recall details

Recall number: Z-0391-2018
Status: Terminated
Initiated by the company: Nov 10, 2017
Recalling firm: Philips Medical Systems (Cleveland) Inc
Quantity: 3
Product code: JAK
FDA submissions: K160743
Distribution: Worldwide Distribution -- US, Argentina, China, Republic of Korea, Russian Federation, Slovakia, Turkey, and United Kingdom. 4 in US, (1 military), 14 foreign accounts

Product description

Ingenuity Core 128, (Code 728323) Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.

Code information (models, lots, serial numbers)

Code 728323, SN # 320394, UDI: (01)00884838059474(21)320394; 320395, UDI: (01)00884838059474(21)320395; and 336286.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Brilliance iCT
Philips Medical Systems Nederland B.V. · System, x-ray, tomography, computed
8 recalls6 reports

Product lines

Brilliance iCTPhilips Medical Systems Nederland B.V. · 2 models · 9 reports · 8 recalls

Other products in the same recall event

The FDA groups related products into one recall event (event 78852).

Z-0388-2018 · Terminated
Brilliance iCT Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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