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Terminated

The Brilliance 6, 10, 16, 40, 64 and CT Big Bore are Computed Tomography X-Ray Systems These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories. Product Usage: The Brilliance 6, 10, 16, 40, 64 and CT Big Bore are Computed Tomography X-Ray Systems that are 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 analysis and display equipment, patient, and equipment supports, components and accessories

FDA Recall Z-2245-2012 · Posted 2012-08-22

Recall StatusTerminated
Product CodeJAK
Date Initiated2012-08-03
Date Terminated2015-07-23
Product Quantity126 units

Reason for Recall

The patient support may move in an unintended manner if the foot switch cover becomes damaged and impinges on the foot switch.

Firm Action

Philips Medical Systems (Cleveland), Inc. sent an Urgent - Medical Device Correction letter dated August 1, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taked. The letter contained important information for the continued safe and proper use of your equipment. The letter stated that, a Field Service Engineer will visit each affected site to install the hardware upgrade. For further information or support concerning this issue contact your local Philips representative or local Philips Health office. For North America and Canada contact Customer Care Solution Center (1-800-722-9377), option 5: Enter Site ID or Follow the prompts).

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution - US Nationwide including the states of: AL, AR, AZ, CA, DC, FL, GA, KY, MD, MI, MN, MS, ND, NM, NY, OH, OK, SC, TN, TX, VT, WA, and WI and the countries of: Austria, China, Denmark, France, Germany, Iceland, Japan, Netherlands, South Africa, Sweden, Switzerland, United Kingdom. There were two government consignees. There were no Canadian consignees.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

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

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