CLASS II Device recall · Reported 24 Sep 2014 · FDA Enforcement Report
The Brilliance 64 and Ingenuity CT are Computed Tomography recalled
Philips Medical Systems (Cleveland) is recalling The Brilliance 64 and Ingenuity CT are Computed Tomography X-Ray Systems intended to, distributed in Ohio. The recall was initiated on 1 Sep 2011 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-2664-2014
- FDA event ID
- 69045
- Recalling firm
- Philips Medical Systems (Cleveland), Cleveland, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Sep 2011
- FDA classified
- 18 Sep 2014
- Reported
- 24 Sep 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 1 Sep 2011 | Recall initiated by company | |
| 18 Sep 2014 | Classified by FDA | +1113 days |
| 24 Sep 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
During a Field Test (a customer external evaluation period), the customer detected a problem in the CIRS 4.0 Beta 2 software. When using the CIRS 4.0 Beta 2 software, during the recon during ready stage of reconstruction, images may be overlapped with, or superimposed on other images. Philips has disabled this feature at all sites evaluating 4.0 Beta 2 software. Philips will issue a software up
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
The Brilliance 64 and Ingenuity CT are 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 distribution in OH and countries of: Australia, China, Belgium, Israel, and Sweden.
Questions about this recall
Why was it recalled?
During a Field Test (a customer external evaluation period), the customer detected a problem in the CIRS 4.0 Beta 2 software. When using the CIRS 4.0 Beta 2 software, during the recon during ready stage of reconstruction, images may be overlapped with, or superimposed on other images. Philips has disabled this feature at all sites evaluating 4.0 Beta 2 software. Philips will issue a software up
Which lots are affected?
91003, 30018, 95504, 300004, 300030, 300010, 95130, 95157
Where was it sold?
Worldwide Distribution: US distribution in OH and countries of: Australia, China, Belgium, Israel, and Sweden.
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.
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