CLASS II Device recall · Reported 14 Mar 2018 · FDA Enforcement Report
IQon Spectral CT recalled by Philips Medical Systems
Philips Medical Systems (Cleveland) is recalling IQon Spectral CT with 4.7.2. The recall was initiated on 11 Jan 2018 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-0841-2018
- FDA event ID
- 79148
- Recalling firm
- Philips Medical Systems (Cleveland), Cleveland, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Jan 2018
- FDA classified
- 2 Mar 2018
- Reported
- 14 Mar 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 11 Jan 2018 | Recall initiated by company | |
| 2 Mar 2018 | Classified by FDA | +50 days |
| 14 Mar 2018 | 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
23 Software related issues for the IQon Spectral CT with 4.7.2 software version. These issues include: " Software errors that may result in CT spectral images misrepresentation or incorrect treatment; " Software errors that may result in partial set of images or inability to generate CT images.
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
IQon Spectral CT with 4.7.2 software version.- Model 728332, a Philips Computed Tomography X-Ray System
Where it was distributed
Domestic and Foreign
Questions about this recall
Why was it recalled?
23 Software related issues for the IQon Spectral CT with 4.7.2 software version. These issues include: " Software errors that may result in CT spectral images misrepresentation or incorrect treatment; " Software errors that may result in partial set of images or inability to generate CT images.
Which lots are affected?
Serial Numbers: 860008 860009 860010 860011 860012 860013 860014 860015 860016 860017 860018 860019 860020 860021 860022 860023 860024 860025 860026 860027 860028 860029 860030 860031 860032 860033 860034 860035 860036 860037 860038 860039 860040 860041 860042 860043 860046 860048 860049 860050 860051 860052 860053 860054 860055 860056 860057 860058 860059 860060 860061 860062 860063 860064 860065 860066 860067 860068 860070 860071 860072 890002 860047
Where was it sold?
Domestic and Foreign
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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