CLASS II Device recall · Reported 18 Jan 2017 · FDA Enforcement Report
Brilliance iCT recalled by Philips Medical Systems
Philips Medical Systems (Cleveland) is recalling Brilliance iCT. The recall was initiated on 25 Nov 2016 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-1004-2017
- FDA event ID
- 76021
- Recalling firm
- Philips Medical Systems (Cleveland), Cleveland, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Nov 2016
- FDA classified
- 11 Jan 2017
- Reported
- 18 Jan 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 25 Nov 2016 | Recall initiated by company | |
| 11 Jan 2017 | Classified by FDA | +47 days |
| 18 Jan 2017 | 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
Failure to correctly document the installation of four M12 Bolts into the system rotor.
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 iCT 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
The one system was distributed in Canada. There were no government or US distribution.
Questions about this recall
Why was it recalled?
Failure to correctly document the installation of four M12 Bolts into the system rotor.
Which lots are affected?
Model Number 728306; System Serial Number 100619 Rorot-45535-673-94382 SN26
Where was it sold?
The one system was distributed in Canada. There were no government or US 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 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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