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Terminated

Brilliance iCT Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories

FDA Recall Z-1004-2017 · Posted None

Recalling FirmPhilips Medical Systems (Cleveland) Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2016-11-25
Date Terminated2018-07-02
Product Quantity1

Reason for Recall

Failure to correctly document the installation of four M12 Bolts into the system rotor.

Firm Action

Philips sent a Customer Information Letter to their customer. The letter identified the affected product, problem description and actions to be taken by customers. For further information or support concerning this issue, contact your local Philips representative or local Philips Healthcare office. For SUPPORT North America and Canada, contact the Customer Care Solutions Center (1-800-722-9377).

Root Cause

Employee error

Distribution Pattern

The one system was distributed in Canada. There were no government or 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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