Recall Z-0841-2018 ยท JAK System, X-Ray, Tomography, Computed
Philips Medical Systems (Cleveland) Inc
IQon Spectral CT with 4.7.2 software version.- Model 728332, a Philips Computed Tomography X-Ray System
| Date | Jan 11, 2018 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | Philips Healthcare is notifying the affected users of these issues via a Field Safety Notice and will be releasing a software fix via Field Change Order to correct these issues. They also provide the following instructions.: Issue 1, Uric acid application for gout provides inconsistent results - When reviewing images using the Uric Acid Spectral Result type inconsistent results were provided on gout studies. The tendons would occasionally be displayed as containing Uric Acid even with no or normal uric acid blood levels. Issue 2, Multi-phase Cardiac CTA Scans should include a planned conv |
| Quantity | 63 |
| Distribution | Domestic and Foreign |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133674 | PHILIPS IQON SPECTRAL CT Philips Healthcare (Cleveland), Nov 21, 2014 |