CLASS II Device recall · Reported 13 May 2020 · FDA Enforcement Report

Philips Brilliance IQon Spectral CT recalled by Philips North America

Philips North America is recalling Philips Brilliance IQon Spectral CT, Computed Tomography X-Ray System, distributed in Iowa. The recall was initiated on 6 Apr 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial #s 860067, 860023

Quantity recalled2

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1923-2020
FDA event ID: 85513
Recalling firm: Philips North America, Andover, MA
Classification: Class II
Status: Terminated
Recall initiated: 6 Apr 2020
FDA classified: 6 May 2020
Reported: 13 May 2020
Type: Voluntary: Firm initiated
Customers notified by: N/A
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

6 Apr 2020	Recall initiated by company
6 May 2020	Classified by FDA	+30 days
13 May 2020	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The bolt affixing the cooling unit to the rotor was not tightened to specification on the Philips Brilliance iCT systems.

Product as listed by the FDA

Philips Brilliance IQon Spectral CT, Computed Tomography X-Ray System; Model # 728332; UDI # (01)00884838059542(21)860067

Where it was distributed

Worldwide distribution including one unit distributed to Iowa.

Iowa

Questions about this recall

Why was it recalled?

The bolt affixing the cooling unit to the rotor was not tightened to specification on the Philips Brilliance iCT systems.

Which lots are affected?

Serial #s 860067, 860023

Where was it sold?

Worldwide distribution including one unit distributed to Iowa.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 85513

This product is part of a recall event; the main page for the event is Philips Brilliance iCT SP Computed Tomography X-Ray System recalled.

Reported	Class	Recall	Company	Reason	Where
13 May 2020	CLASS II	Philips Brilliance iCT SP Computed Tomography X-Ray System recalled	Philips North America	Other	IA
13 May 2020	CLASS II	Philips Brilliance iCT Computed Tomography X-Ray System recalled	Philips North America	Other	IA

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