Food, drugs, devices › Philips Medical Systems (Cleveland) Inc
Device recall: IQon Spectral CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by compute
Philips Medical Systems (Cleveland) Inc (Cleveland, OH) initiated this device recall on 14 Nov 2016; FDA lists 2 product records under event 75755, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,232 device enforcement events initiated in 2016 carry the same class.
Status: Terminated, terminated 2 Jul 2018. Initiation: voluntary: firm initiated. Philips Medical Systems (Cleveland) Inc has 129 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Philips Medical Systems (Cleveland) Inc, Cleveland, OH.
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"
Distribution
"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…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0705-2017 | 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. | 24 | Class II | Terminated | 14 Dec 2016 |
| Z-0706-2017 | Philips Spectral CT Applications supports viewing and analysis of images at energies selected from the available spectrum in order to provide information about the chemical composition of the body materials and/or contrast agents. | 20 | Class II | Terminated | 14 Dec 2016 |
Context
Other enforcement events for Philips Medical Systems (Cleveland) Inc
All 129 events for Philips Medical Systems (Cleveland) Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "A software defect is causing issues with the IQon Spectral CT and Philips Spectral CT Applications while filming, saving and annotating images"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "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…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 2 Jul 2018. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.