Enforcement Report - Week of March 20, 2013
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Product Detail
| Product Description | Brilliance 64 and Ingenuity Computed Tomography X-Ray Systems The Brilliance 64 and Ingenuity CT are whole body 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. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories. |
|---|---|
| Recall Number | Z-0950-2013 |
| Classification | Class II |
| Code Info | Brilliance 64: 728231 & Ingenuity CT: 728326, 728323. System Code # 728231, Serial #: 9654, 91003, 95130, 95157, 95504 System Code # 728326, Serial #: 32000,300003,300004,300005,300010,300011,300012,300014,300015,300018,300027,300041,300053,300059,300066,300070,300071,300073,300074,300078,300079,300080,300082,300084,300086,300091,300095,300101,300102,300112,300127,300128,300129,300131,300132,310064 System Code # 728323, Serial #: 320033 |
| Product Distributed Qty | 42 Units |
| Reason For Recall | This field change order is being released to update software and customer release notes to the affected installed base. |
Event Detail
| Event Id | 64436 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Philips Medical Systems (Cleveland) Inc |
| City | Cleveland |
| State | OH | Country | US |
| Voluntary / Mandated | |
| Recall Initiation Date | 2013-02-15 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Worldwide Distribution - USA including AR, AZ, IN, KS, LA, MA, MN, MS, MT, NJ, NY, NY, OH, OR, PA, TN, TX, VT, WV, WY, and worldwide including the contries of Australia, Belgium, China, France, Germany, Israel, Japan, Norway, Sweeden, and Switzerland. |
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