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Terminated

Brilliance iCT SP - Model 728311 Brilliance iCT - Model 728306 Computed Tomography X-ray systems

FDA Recall Z-0402-2018 · Posted None

Recalling FirmPhilips Medical Systems (Cleveland) Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2017-07-11
Date Terminated2019-07-02
Product Quantity559 total

Reason for Recall

Numerous software issues with Brilliance iCT 4.1.6 version. Issues affect scan start position, data acquisition, exam stop, tube overheat, memory overflow, failure to give error message, length of acquisition, image volume and other functions.

Firm Action

A Customer Information Letter dated June 29, 2017, was sent to US consignees via certified mail. Philips Key Market representatives will distribute the letter internationally, based on local regulations. Additionally, a Field Service Engineer will contact each site to schedule a time to implement the Field Change Order.

Root Cause

Software design

Distribution Pattern

Worldwide distribution, including US nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K060937BRILLIANCE VOLUMEPhilips Medical Systems (Cleveland), Inc. · 2006-06-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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