CLASS II Device recall · Reported 17 Jan 2018 · FDA Enforcement Report
Philips Healthcare Brilliance iCT SP computed tomography recalled
Philips Medical Systems (Cleveland) is recalling Philips Healthcare Brilliance iCT SP computed tomography x-ray system. The recall was initiated on 8 Nov 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-0332-2018
- FDA event ID
- 78879
- Recalling firm
- Philips Medical Systems (Cleveland), Cleveland, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Nov 2017
- FDA classified
- 11 Jan 2018
- Reported
- 17 Jan 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 8 Nov 2017 | Recall initiated by company | |
| 11 Jan 2018 | Classified by FDA | +64 days |
| 17 Jan 2018 | 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
There is a possibility that screws holding an internal portion of the gantry (Reaction Ring) to the scanner s main bearing may come loose. If this occurs, the part(s) will not be expelled, however, a noise may be heard coming from the gantry.
Product as listed by the FDA
Philips Healthcare Brilliance iCT SP computed tomography x-ray system
Where it was distributed
107 domestic accounts 15 US Govt accounts 682 Foreign Accounts 3 Mexico accounts 12 Canada accounts
Questions about this recall
Why was it recalled?
There is a possibility that screws holding an internal portion of the gantry (Reaction Ring) to the scanner s main bearing may come loose. If this occurs, the part(s) will not be expelled, however, a noise may be heard coming from the gantry.
Which lots are affected?
Brilliance iCT SP - 728311 Devices manufactured 03/05/2009 to present.
Where was it sold?
107 domestic accounts 15 US Govt accounts 682 Foreign Accounts 3 Mexico accounts 12 Canada accounts
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.
Other products in this recall event
2 other products · FDA event 78879This product is part of a recall event; the main page for the event is Philips Healthcare Brilliance iCT computed tomography x-ray system recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Philips Healthcare Brilliance iCT computed tomography x-ray system recalled | Philips Medical Systems (Cleveland) | Other | OH | |
| CLASS II | Philips Healthcare IQon Spectral CT computed tomography x-ray system recalled | Philips Medical Systems (Cleveland) | Other | OH |
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