Recall Z-0705-2017 ยท JAK System, X-Ray, Tomography, Computed
Philips Medical Systems (Cleveland) Inc
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.
| Date | Nov 14, 2016 |
| Status | Terminated |
| Reason | A software defect is causing issues with the IQon Spectral CT and Philips Spectral CT Applications while filming, saving and annotating images |
| Root cause | Software design |
| Action | A Field Safety Notice (Attachment #1 Field Safety Notice FSN 16-061-72800659 and FSN 88100051), will be sent to US consignees via certified mail. Philips Key Market representatives will distribute the notice internationally, based on local regulations. Additionally, a Field Service Engineer will contact each site to schedule a time to implement the Field Change Order. |
| Quantity | 24 |
| 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 and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133674 | PHILIPS IQON SPECTRAL CT Philips Healthcare (Cleveland), Nov 21, 2014 |