CLASS II Device recall · Reported 1 Feb 2017 · FDA Enforcement Report
Brilliance iCT recalled by Philips Medical Systems
Philips Medical Systems (Cleveland) is recalling Brilliance iCT. The recall was initiated on 23 Dec 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-1058-2017
- FDA event ID
- 76144
- Recalling firm
- Philips Medical Systems (Cleveland), Cleveland, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Dec 2016
- FDA classified
- 20 Jan 2017
- Reported
- 1 Feb 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 23 Dec 2016 | Recall initiated by company | |
| 20 Jan 2017 | Classified by FDA | +28 days |
| 1 Feb 2017 | 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
During a retrospective review of production documentation it was observed that the M6 Rotor Counterweight Bolt may have been improperly torqued.
Product as listed by the FDA
Brilliance iCT
Where it was distributed
Product was not distributed in the US. Unit was distributed in Australia.
Questions about this recall
Is Brilliance iCT recalled?
Yes. Philips Medical Systems (Cleveland) recalled Brilliance iCT on 23 Dec 2016. The recall is Class II and its status is Terminated. Recall number Z-1058-2017.
Why was it recalled?
During a retrospective review of production documentation it was observed that the M6 Rotor Counterweight Bolt may have been improperly torqued.
Which lots are affected?
Rotor-4535-673-94382 SN 19, installed on Brilliance ICT System S/N 200203
Where was it sold?
Product was not distributed in the US. Unit was distributed in Australia.
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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