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U.S. Department of Health and Human Services

Enforcement Report - Week of August 29, 2012

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Product Detail

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
Recall Number Z-2245-2012
Classification Class II
Code Info System Code # 728243, Serial #s: 7392, 7394, 7399, 7405, 7406, 7429, 7433, 7440, 7457, 7465, 7469, 7479, 7481, 7487, 7488, 7491, 7502, 7506, 7507, 7517, 7518, 7520, 7521, 7532, 7539, 7545, 7547, and 7556. System Code # 728244, Serial #s: 7190, 7195, 7318, 7383, 7427, 7430, 7510, and 7533. System Code #728256, Serial #s: 3163, 3500, 3500, 5623, 5655, 5655, 5666, 5670, 5715, 5724, 5747, 5773, 5776, 5813, 5836, 5855, 5862, 5868, 5877, 5897, 5911, 5911, 5916, 5935, 5969, and 5997. System Code #728251, Serial #: 4051. System Code # 728246, Serial #s: 5547, 5585, 5791, 5803, 5876, 5974. System Code # 728235, Serial #s: 9233, 9234, 9261, 95022. System Code # 728231, Serial #s: 9867, 9925, 9931, 9980, 9996, 10009, 10011, 10015, 10028, 10036, 10042, 10045, 10050, 10052, 10062, 10063, 10064, 10077, 10079, 10081, 10096, 10099, 10102, 10111, 10114, 10120, 10122, 10133, 10135, 10136, 10137, 10139, 10145, 10148, 10149, 10151, 10153, 10166, 10170, 10172, 10198, 10203, 95109, 95348, 95563.
Product Distributed Qty 126 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.

Event Detail

Event Id 62790
Product Type Devices
Status Ongoing
Recalling Firm Philips Medical Systems (Cleveland) Inc
City Cleveland
State OH
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-08-03
Initial Firm Notification of Consignee or Public Letter
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.
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