CLASS II Device recall · Reported 10 Jun 2015 · FDA Enforcement Report
Brilliance iCT Computed Tomography X-ray system recalled
Philips Medical Systems (Cleveland) is recalling Brilliance iCT Computed Tomography X-ray system. The recall was initiated on 13 Apr 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-1695-2015
- FDA event ID
- 71231
- Recalling firm
- Philips Medical Systems (Cleveland), Cleveland, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Apr 2015
- FDA classified
- 29 May 2015
- Reported
- 10 Jun 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 13 Apr 2015 | Recall initiated by company | |
| 29 May 2015 | Classified by FDA | +46 days |
| 10 Jun 2015 | 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
A calibrated torque wrench malfunctioned at the supplier leading to possible incorrect torque of x-ray tube mounting fasteners.
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 Computed Tomography X-ray system
Where it was distributed
Internationally to the countries of China and Norway.
Questions about this recall
Why was it recalled?
A calibrated torque wrench malfunctioned at the supplier leading to possible incorrect torque of x-ray tube mounting fasteners.
Which lots are affected?
Model# 728306; Serial #'s: 85019 & 85023.
Where was it sold?
Internationally to the countries of China and Norway.
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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