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Terminated

Philips Brilliance 64 computed tomography x-ray system

FDA Recall Z-0518-2018 · Posted None

Recalling FirmPhilips Medical Systems (Cleveland) Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2017-10-06
Date Terminated2019-07-02
Product Quantity1801

Reason for Recall

Numerous issues related to software Brilliance iCT 4.1.6 software version.

Firm Action

Philips Medical Systems (Cleveland), Inc. sent the Customer Information Letter via certified letters mail with returned receipts. Also, a Field Service Engineer will perform the software update on the system to resolve the issues. Implementation of the software update will be monitored.

Root Cause

Software design

Distribution Pattern

26 US Govt accounts

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K160743Philips Ingenuity CTPhilips Medical Systems (Cleveland), Inc. · 2016-08-08

Official Source

View FDA Recall →

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

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