Recall Z-0017-2018 ยท JAK System, X-Ray, Tomography, Computed
Philips Electronics North America Corporation
Philips Healthcare Ingenuity CT X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
| Date | Jan 18, 2017 |
| Status | Terminated |
| Reason | During a bolus tracking procedure, no images were generated when the scan was completed, and the raw data file was not available for offline reconstruction. There is a discrepancy between the calculated reconstruction length and the actual scan length that results in the inability to reconstruct raw data. The operator may choose to rescan the patient. |
| Root cause | Process design |
| Action | Philips will bring defect into compliance: 1. Will issue a customer notification letter. 2. Will provide a software update, at no cost to the customer. CDRH approves the CAP subject to the following conditions: 1.Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2. You will implement this CAP by April 30, 2018. If you need any furthe |
| Quantity | US - 606 |
| Distribution | USA (nationwide) Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.