CLASS II Device recall · Reported 5 Aug 2015 · FDA Enforcement Report

Computed Tomography X-ray Systems Brilliance iCT SP recalled

Philips Medical Systems (Cleveland) is recalling Computed Tomography X-ray Systems Brilliance iCT SP, distributed nationwide in the US. The recall was initiated on 5 Feb 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel #728311; Serial #s: 200047 & 200121

Quantity recalled2 units

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-2256-2015
FDA event ID: 71124
Recalling firm: Philips Medical Systems (Cleveland), Cleveland, OH
Classification: Class II
Status: Terminated
Recall initiated: 5 Feb 2015
FDA classified: 24 Jul 2015
Reported: 5 Aug 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

5 Feb 2015	Recall initiated by company
24 Jul 2015	Classified by FDA	+169 days
5 Aug 2015	Published in enforcement report	+12 days

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

Reason for recall

5 issues. Fast Get Ready incorrectly enabled during service procedures. Contrast annotation missing for some images when manual contrast was administered. Dot artifact present, intermittently, after startup. Heart Rate measured value incorrectly remains constant for some heart rate change conditions. DoseRight incorrectly enabled when the Exam Card specified disabling DoseRight. Tube heat predict

Product as listed by the FDA

Computed Tomography X-ray Systems Brilliance iCT SP. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

Where it was distributed

Worldwide Distribution-US (nationwide) including the states of AR, AZ, CA, CT, DE, FL, GA, IA, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VT, WV & WY, and to the following countries: Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Cambodia, Canada, China, Colombia, Denmark, Finland, France, Germany, Hong Kong, India, Indonesia, Iran, Iraq, Ireland, Italy, Japan, Latvia, Libyan Arab Jamahiriya, Lithuania, Malaysia, Mexico, Myanmar, Netherlands, New Zealand, Norway, Panama, Philippines, Russia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Viet Nam.

Nationwide Arkansas Arizona California Connecticut Delaware Florida Georgia Iowa Indiana Kansas Louisiana Massachusetts Maryland Michigan Minnesota Missouri Mississippi Montana New Hampshire New Jersey

Questions about this recall

Is Computed Tomography X-ray Systems Brilliance iCT SP recalled?

Yes. Philips Medical Systems (Cleveland) recalled Computed Tomography X-ray Systems Brilliance iCT SP on 5 Feb 2015. The recall is Class II and its status is Terminated. Recall number Z-2256-2015.

Why was it recalled?

Which lots are affected?

Model #728311; Serial #s: 200047 & 200121

Where was it sold?

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

More recalls from Philips Medical Systems (Cleveland)

All 315

Reported	Class	Recall	Company	Reason	Where
24 Sep 2025Device	CLASS II	Pinnacle Radiation Therapy Planning System recalled	Philips Medical Systems (Cleveland)	Packaging Defects	Nationwide
13 Aug 2025Device	CLASS II	Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System recalled	Philips Medical Systems (Cleveland)	Device Malfunction	Nationwide
21 Sep 2022Device	CLASS II	Pinnacle3 Radiation Therapy Planning System recalled	Philips Medical Systems (Cleveland)	Other	21 states
13 Nov 2019Device	CLASS I	Forte Gamma Camera System is intended to produce images recalled	Philips Medical Systems (Cleveland)	Other	Nationwide
13 Nov 2019Device	CLASS I	Forte Gamma Camera System is intended to produce images recalled	Philips Medical Systems (Cleveland)	Other	Nationwide

Other Imaging Equipment recalls

All 2,336

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Lead & Heavy Metals	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits: Ultrasound Breast Pack recalled	Medline Industries	Sterility	Nationwide
2 Sep 2026Device	CLASS II	Alphenix Models Infx-8000C Infx-8000F Infx-8000V This device is recalled	Canon Medical System, USA	Other	Nationwide
2 Sep 2026Device	CLASS II	Merge PACS and Merge OrthoPACS recalled by Merge Healthcare	Merge Healthcare	Labeling Errors	Nationwide
19 Aug 2026Device	CLASS II	Philips Azurion recalled by Philips Medical Systems	Philips Medical Systems Nederland B.v	Lead & Heavy Metals