Recall Z-1316-2026— Philips North America Llc

Name: FDA recall Z-1316-2026
Creator: U.S. Food and Drug Administration
Published: 2026-01-07

Class II · Ongoing

Class II FDA medical device recall by Philips North America Llc, initiated 2026-01-07. It names one FDA 510(k) clearance: K193454. Product: IQon Spectral CT; Product Code (REF): 728332;. Reason: 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..

Recalling firm: Philips North America Llc
Classification: Class II
Status: Ongoing
Initiated: 2026-01-07
Firm location: Cambridge, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K193454 — IQon Spectral CTPhilips Medical Systems Nederland B.V.·cleared 2020-01-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

IQon Spectral CT; Product Code (REF): 728332;

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.