Recall Z-1006-2017 ยท JAK System, X-Ray, Tomography, Computed
Philips Medical Systems (Cleveland) Inc
IQon Spectral CT with software version 4.7.0 Product Usage: The 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. This device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories. The
| Date | Dec 16, 2016 |
| Status | Terminated |
| Reason | Multiple issues have caused the device to result in CT rescans or incorrect scan location or misrepresentation of image results. |
| Root cause | Software design |
| Action | Philips sent a Customer Information Letter dated December 13, 2016 to customers via certified mail. The letter identified the affected product, problem and actions to be taken. Additionally, a Field Service Engineer will contact each site to schedule a time to implement the Field Change Order. For further information or support concerning this issue contact your local Philips representative or local Philips Healthcare office. For North America and Canada, contact the Customer Care Solutions Center (1-800-722-9377). |
| Quantity | 35 |
| Distribution | Worldwide Distribution - US Nationwide in the states of AR, IN, LA, MA, MN, OR, TN & TX. and the countries: Australia, Belgium, Denmark, France, Germany, Israel, Japan, Republic of Korea, Poland, Portugal, Slovenia, Switzerland, Thailand 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 |