Agency classClass IIOur severity:High FDA (Devices)·Z-1315-2026·Announced 2026-02-18

Brilliance iCT scanners recalled over rotor fasteners that may be undertorqued

Philips is recalling 47 units of the Brilliance iCT because fasteners attaching the rotor to the gantry bearing may not be torqued to specification.

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: Scored 3 under the risk-of-harm criterion: the firm states unsecured rotor parts may potentially be expelled during gantry rotation, and no such event or injury has been reported.

Plain-English summary

The Philips Brilliance iCT, product code (REF) 728306, is being recalled by Philips North America Llc.

The record states that as part of the CT system sub assembly, 32 fasteners are used to attach the rotor to the bearing within the gantry, and that 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. The record states that while there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled.

The record lists 47 units under UDI-DI 00884838059474, with serial numbers recorded in the enforcement record. Distribution was worldwide, including nationwide in the United States across the states listed in the record. The FDA has classified the action as Class II.

The enforcement record reports no injuries. Facilities should follow Philips' instructions.

The recalled product

Product: Brilliance iCT; Product Code (REF): 728306;
Manufacturer: Philips North America Llc
Category: Medical Device — CT scanner
Hazard: fastener-torque
rotor-displacement
expelled-parts
Affected units: 47

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)

Product Code (REF): 728306
UDI-DI: 00884838059474
Serial Numbers: 87064
87120
87121
87122
87125
87126
87127
87128
87129
87130
87135
87143
87148
87152
87153
87157
87160
87162

Distribution

Distributed nationwide across the United States.

The notice also names 24 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Philips North America Llc 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 4 products in this recall →

Same manufacturer · Philips North America Llc

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Same hazard · fastener torque