CLASS II Device recall · Reported 14 Dec 2016 · FDA Enforcement Report
IQon Spectral CT is a Computed Tomography X-Ray System recalled
Philips Medical Systems (Cleveland) is recalling IQon Spectral CT is a Computed Tomography X-Ray System intended to produce, distributed in 7 states. The recall was initiated on 14 Nov 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-0705-2017
- FDA event ID
- 75755
- Recalling firm
- Philips Medical Systems (Cleveland), Cleveland, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Nov 2016
- FDA classified
- 3 Dec 2016
- Reported
- 14 Dec 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 14 Nov 2016 | Recall initiated by company | |
| 3 Dec 2016 | Classified by FDA | +19 days |
| 14 Dec 2016 | Published in enforcement report | +11 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A software defect is causing issues with the IQon Spectral CT and Philips Spectral CT Applications while filming, saving and annotating 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 is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Where it was distributed
Software was distributed in the following states: AR, IN, LA, MA, MN, OR and TN. Softward was also shipped to the following countries: Belgium, Denmark, France, Germany, Japan, Korea, Switzerland and United Kingdom.
ArkansasIndianaLouisianaMassachusettsMinnesotaOregonTennessee
Questions about this recall
Why was it recalled?
A software defect is causing issues with the IQon Spectral CT and Philips Spectral CT Applications while filming, saving and annotating images
Which lots are affected?
860008 860009 860010 860011 860012 860013 860014 860015 860016 860017 860018 860019 860020 860021 860022 860023 860024 860028 860026 860029 860030 860031 860034 860035
Where was it sold?
Software was distributed in the following states: AR, IN, LA, MA, MN, OR and TN. Softward was also shipped to the following countries: Belgium, Denmark, France, Germany, Japan, Korea, Switzerland and United Kingdom.
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
1 other product · FDA event 75755This product is part of a recall event; the main page for the event is Philips Spectral CT Applications supports viewing recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Philips Spectral CT Applications supports viewing recalled | Philips Medical Systems (Cleveland) | Device Malfunction | 7 states |
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