FDA Device Recall Z-0015-2018: Philips Electronics North America Corporation

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0015-2018.

Recall Res Number

Z-0015-2018

Recalling Firm / Manufacturer

Philips Electronics North America Corporation

FEI Number

1218950

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2017-01-18

Date Posted

N/A

Date Terminated

2020-02-26

Product Code

JAK

Event Number

78144

Product Quantity

US - 606

Product Description Philips Healthcare Brilliance 64 System, 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.

Reason for Recall 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.

Action Details 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. .

Distribution Pattern USA (nationwide) Distribution

Code Information / Serial Numbers Software version 4.16

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Medical Device Recall: Z-0015-2018

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer