Official recall record

Brilliance iCT; Product Code (REF): 728306;

US FDA — Medical Devices · 2026-01-07 · United StatesClass II

Issuing authority: US FDA — Medical Devices
Recall initiated by firm: 2026-01-07
Country of alert: United States
Alert level: Class II
Alert type: recall
Barcode (EAN/GTIN): 00884838059474
Brand on record: Philips North America Llc

What the authority reported

As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured or displaced. While there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled.

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

More recalls: US FDA — Medical Devices · United States · all filters

Same barcode in other registries

The same EAN appears in 6 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.

2017-11-10 · US FDA — Medical Devices
Ingenuity Core 128, (Code 728323) Intended to produce images of the head and body by computer reconstruction of x-ray
2020-04-06 · US FDA — Medical Devices
Philips Brilliance iCT Computed Tomography X-Ray System; Model # 728306; UDI #s (01)00884838059474(21)100783, (01)008848
2021-06-08 · US FDA — Medical Devices
728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT Upgrades
2025-08-13 · US FDA — Medical Devices
Philips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306.
2017-11-10 · US FDA — Medical Devices
Brilliance iCT Intended to produce images of the head and body by computer reconstruction of x-ray transmission data

Other recalls from this brand

All 58 official recall notices naming Philips North America on this site →

ProductGuru Recalls republishes official safety information with attribution. We are not the issuing authority and this page is not advice. If this product is a medical device or medication, speak to a doctor or pharmacist. Found an error? Report it — corrections are published.