PlainRecalls
FDA Devices Moderate Class II 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 incl

Reported: August 29, 2012 Initiated: August 3, 2012 #Z-2245-2012

Product Description

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

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.

Details

Units Affected
126 units
Distribution
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.
Location
Cleveland, OH

Frequently Asked Questions

What product was recalled? ▼
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. Recalled by Philips Medical Systems (Cleveland) Inc. Units affected: 126 units.
Why was this product recalled? ▼
The patient support may move in an unintended manner if the foot switch cover becomes damaged and impinges on the foot switch.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 29, 2012. Severity: Moderate. Recall number: Z-2245-2012.

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