Enforcement Report - Week of August 29, 2012
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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. |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| 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 | 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. | Class II | The patient support may move in an unintended manner if the foot switch cover becomes damaged and impinges on the foot switch. | 126 units | Z-2245-2012 |
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