CLASS II Device recall · Reported 30 Dec 2015 · FDA Enforcement Report
Brilliance 64 Computed Tomography X-ray system recalled
Philips Medical Systems (Cleveland) is recalling Brilliance 64 Computed Tomography X-ray system, distributed nationwide in the US. The recall was initiated on 29 Oct 2015 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-0544-2016
- FDA event ID
- 72684
- Recalling firm
- Philips Medical Systems (Cleveland), Cleveland, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Oct 2015
- FDA classified
- 24 Dec 2015
- Reported
- 30 Dec 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 29 Oct 2015 | Recall initiated by company | |
| 24 Dec 2015 | Classified by FDA | +56 days |
| 30 Dec 2015 | 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
Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions preceding 4.1.2) without buying the helical perfusion license key could not access the basic axial perfusion feature after upgrading to software version 4.1.2.
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 Computed Tomography X-ray system
Where it was distributed
Worldwide distribution. US nationwide, Australia, Austria, Bangladesh, Belgium, Brazil, Cambodia, Canada, China, Egypt, France, Germany, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Korea, Lebanon, Libya, Lithuania, Malaysia, Martinique, Myanmar, Mexico, Mozambique, Netherlands, New Zealand, Norway, Palestine, Panama, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Vietnam.
Questions about this recall
Is Brilliance 64 Computed Tomography X-ray system recalled?
Yes. Philips Medical Systems (Cleveland) recalled Brilliance 64 Computed Tomography X-ray system on 29 Oct 2015. The recall is Class II and its status is Terminated. Recall number Z-0544-2016.
Why was it recalled?
Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions preceding 4.1.2) without buying the helical perfusion license key could not access the basic axial perfusion feature after upgrading to software version 4.1.2.
Which lots are affected?
Model No. 728231; S/N: 4001, 9074, 9099, 9538, 9549, 9573, 9638, 9646, 9656, 9667, 9703, 9738, 9755, 9782, 9811, 9822, 9909, 9923, 9927, 9933, 10021, 10042, 10077, 10150, 10180, 10379, 29056, 29107, 29115, 90124, 90154, 95024, 95130, 95222, 95236, 95258, 95261, 95364, 95399, 95410, 95475, 95551, 95614, 95668, 95688 & 95691.
Where was it sold?
Worldwide distribution. US nationwide, Australia, Austria, Bangladesh, Belgium, Brazil, Cambodia, Canada, China, Egypt, France, Germany, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Korea, Lebanon, Libya, Lithuania, Malaysia, Martinique, Myanmar, Mexico, Mozambique, Netherlands, New Zealand, Norway, Palestine, Panama, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Vietnam.
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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