CLASS II Device recall · Reported 7 Nov 2018 · FDA Enforcement Report
Brilliance 64 (Model No. 728231), Software version 4.1.6 Product recalled
Philips Medical Systems (Cleveland) is recalling Brilliance 64 (Model No. 728231), Software version 4.1.6 Product, distributed nationwide in the US. The recall was initiated on 7 Jun 2017 and the FDA has classified it as Class II.
Check your package
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-0304-2019
- FDA event ID
- 81403
- Recalling firm
- Philips Medical Systems (Cleveland), Cleveland, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Jun 2017
- FDA classified
- 31 Oct 2018
- Reported
- 7 Nov 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Imaging Equipment
Timeline
| 7 Jun 2017 | Recall initiated by company | |
| 31 Oct 2018 | Classified by FDA | +511 days |
| 7 Nov 2018 | 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
It was reported that scanners running certain software versions provide confusing information in the "Impressions" section of the Calcium Score report. The generated report provides multiple analyses of the amount of plaque detected, as if they all apply to the patient at the same time. This misleading guidance can be potentially misleading to the user, and may lead to mistreatment of the patient.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
Brilliance 64 (Model No. 728231), Software version 4.1.6 Product Usage: 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 analysts and display equipment, patient and equipment supports, components, and accessories.
Where it was distributed
US Nationwide Distribution
Questions about this recall
Is Brilliance 64 (Model No. 728231), Software version 4.1.6 Product recalled?
Yes. Philips Medical Systems (Cleveland) recalled Brilliance 64 (Model No. 728231), Software version 4.1.6 Product on 7 Jun 2017. The recall is Class II and its status is Terminated. Recall number Z-0304-2019.
Why was it recalled?
It was reported that scanners running certain software versions provide confusing information in the "Impressions" section of the Calcium Score report. The generated report provides multiple analyses of the amount of plaque detected, as if they all apply to the patient at the same time. This misleading guidance can be potentially misleading to the user, and may lead to mistreatment of the patient.
Which lots are affected?
Software Version 4.1.6
Where was it sold?
US Nationwide Distribution
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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