CLASS II Device recall · Reported 14 Dec 2016 · FDA Enforcement Report

Brilliance 64 728232 Computed Tomography X-ray systems recalled

Philips Medical Systems (Cleveland) is recalling Brilliance 64 728232 Computed Tomography X-ray systems intended to produce, distributed nationwide in the US. The recall was initiated on 12 Nov 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes122921, 123029, 123092, 123096, 123116, 123117, 123148, 123150, 123164, 123170, 123172, 123176, 123179, 123180, 123182, 123183, 123185 and 123191

Quantity recalled18

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-0694-2017
FDA event ID: 75756
Recalling firm: Philips Medical Systems (Cleveland), Cleveland, OH
Classification: Class II
Status: Terminated
Recall initiated: 12 Nov 2016
FDA classified: 2 Dec 2016
Reported: 14 Dec 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

12 Nov 2016	Recall initiated by company
2 Dec 2016	Classified by FDA	+20 days
14 Dec 2016	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

Software error due to the filament on timer

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Brilliance 64 728232 Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment supports, components, and accessories

Where it was distributed

Worldwide Distribution - US including AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY and Internationally to Algeria, Argentina, Australia, Austria, Bangladeshm Belgium, Bolivia, Brazil, Cambodia, Canada, Chile, China, Colombia, Croatia, Cuba, Czech Republic, Denmark, Djbouti, Dominican Republic, Egypt, Estonia, Finland, France, Germany, Gibraltar, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Korea, Latvia, Lebanon, Lithuania, Malaysia, Martinique, Mexico, Monaco, Mongolia, Mozambique, Myanmar, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestinian territory, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Russian Federation, Rwanda, Saudi Aarabia, Senegal, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uzbekistan, and Vietnam.

Nationwide Alaska Alabama Arkansas Arizona California Colorado Connecticut Delaware Florida Georgia Iowa Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine Michigan

Questions about this recall

Is Brilliance 64 728232 Computed Tomography X-ray systems intended to produce recalled?

Yes. Philips Medical Systems (Cleveland) recalled Brilliance 64 728232 Computed Tomography X-ray systems intended to produce on 12 Nov 2016. The recall is Class II and its status is Terminated. Recall number Z-0694-2017.

Why was it recalled?

Software error due to the filament on timer

Which lots are affected?

122921, 123029, 123092, 123096, 123116, 123117, 123148, 123150, 123164, 123170, 123172, 123176, 123179, 123180, 123182, 123183, 123185 and 123191

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.

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