CLASS II Device recall · Reported 24 Jan 2018 · FDA Enforcement Report
Brilliance iCT Intended to produce images of the head recalled
Philips Medical Systems (Cleveland) is recalling Brilliance iCT Intended to produce images of the head and body by computer reconstruction. The recall was initiated on 10 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-0388-2018
- FDA event ID
- 78852
- Recalling firm
- Philips Medical Systems (Cleveland), Cleveland, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Nov 2017
- FDA classified
- 18 Jan 2018
- Reported
- 24 Jan 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 10 Nov 2017 | Recall initiated by company | |
| 18 Jan 2018 | Classified by FDA | +69 days |
| 24 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
Philips has identified that certain fasteners cannot be confirmed to have been torqued according to specification. If the fasteners were not torqued as specified and a failure occurs while the system is in use, the parts secured by the fasteners may become loose, which may have a potential for harm.
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 Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Where it was distributed
Worldwide Distribution -- US, Argentina, China, Republic of Korea, Russian Federation, Slovakia, Turkey, and United Kingdom. 4 in US, (1 military), 14 foreign accounts
Questions about this recall
Why was it recalled?
Philips has identified that certain fasteners cannot be confirmed to have been torqued according to specification. If the fasteners were not torqued as specified and a failure occurs while the system is in use, the parts secured by the fasteners may become loose, which may have a potential for harm.
Which lots are affected?
Code 728306, SN# 100776, UDI: (01)00884838059474(21)100776; 100778, UDI: (01)00884838059474(21)100778; 100779, UDI: (01)00884838059474(21)100779; 100780, UDI: (01)00884838059474(21)100780; 100781, UDI: (01)00884838059474(21)100781; 100782, UDI: (01)00884838059474(21)100782; 100783, UDI: (01)00884838059474(21)100783; 100784, UDI: (01)00884838059474(21)100784; 100785, UDI: (01)00884838059474(21)100785; 100787, UDI: (01)00884838059474(21)100787; 100790, UDI: (01)00884838059474(21)100790; 100791, UDI: (01)00884838059474(21)100791; and 100794, UDI: (01)00884838059474(21)1007.
Where was it sold?
Worldwide Distribution -- US, Argentina, China, Republic of Korea, Russian Federation, Slovakia, Turkey, and United Kingdom. 4 in US, (1 military), 14 foreign 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
3 other products · FDA event 78852This product is part of a recall event; the main page for the event is Ingenuity Core 128 recalled by Philips Medical Systems.
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