Recall Z-0311-2019 ยท JAK System, X-Ray, Tomography, Computed
Philips Medical Systems (Cleveland) Inc
Brilliance iCT SP (Model No. 728311, Software Version 4.7.0 or 4.7.2 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.
| Date | Jun 7, 2017 |
| Status | Terminated |
| Reason | It was reported that scanners running certain software versions provide confusing information in the "Impressions" section of the Calcium Score report. The generated report provides multiple analyses of the amount of plaque detected, as if they all apply to the patient at the same time. This misleading guidance can be potentially misleading to the user, and may lead to mistreatment of the patient. |
| Root cause | Software design |
| Action | The recalling firm sent Customer Information letters dated June 7, 2017, to affected customers. The letter notified customers of the product issue. Customers were instructed to determine whether they had a potentially affected system by checking the software version of their device. Customers were reminded that the "Impressions" section of the report is not intended for diagnostic use. Users should instead focus on the total calcium score shown in the "Findings" section, the coronary artery score(s) and/or the "Age and Gender" graph as identified in the Instructions for Use (IFU). The firm se |
| Quantity | 626 |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171850 | Philips CT Big Bore Philips Medical Systems (Cleveland), Inc., Nov 9, 2017 |