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Terminated

Philips Brilliance iCT Computed Tomography X-Ray System Product Usage: The Brilliance iCT/Brilliance iCT SP is a Computed Tomography X-Ray System intended to produce crosssectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. (d) A description of the defect in the

FDA Recall Z-0236-2015 · Posted 2014-12-16

Recalling FirmPhilips Medical Systems, Inc.
Recall StatusTerminated
Product CodeJAK
Date Initiated2014-07-31
Date Terminated2017-02-16
Product Quantity16 systems

Reason for Recall

It was discovered that a software defect may result in the scanner not terminating the CT scan at the intended location.

Firm Action

Philips Healthcare is directly notifying affected users via letter. In addition, Philips Healthcare has performed the software correction for forward production and plans a Field Correction to fix the defect in the field. If you need any further information or support concerning this issue, please contact your local Philips representative or local Philips Healthcare office.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

US Distribution

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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