Device Recall XRay, Tomography, Computed 의 리콜

Recall

78144

Class 2

Z-0016-2018

2017-01-18

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158767

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.

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 further information or support concerning this issue, please contact your local Philips representative or the Customer Care Solutions Center at 1-800-722 9377. .