Enforcement Report - Week of December 12, 2012
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Product Detail
| Product Description | NeuViz 16 Multi-Sliced CT Scanner System, part number 989605858501. NeuViz Dual series CT Scanner System, part number 989605651321 The NeuViz 16 CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously. |
|---|---|
| Recall Number | Z-0466-2013 |
| Classification | Class II |
| Code Info | NeuViz 16 system Serial numbers: N16E090002, N16E090003, N16E090004, N16E090007, N16E090008, N16E090010, N16E100015, N16E100017, N16E100023, N16E110016, N16E110023, N16E110026, N16E110027, N16E110040, N16E110053, N16E120016, N16E120022, N16E120020, N16E120023, N16E120024. Neuviz Dual Serial numbers: 400562, 400563, 400626, NDH009EI, NDH011EI, NDH012EI, NDH013EI, NDH016EI, NDH017EI, NDH026EI, NDH027EI, NDH028EI, NDH030EI, NDH031EI, NDH034EI, NDHR080001, NDHR080002, NDHR080003, NDHR080004, NDHR080007, NDHR080012, NDHR080021, NDHR090003, NDHR090012, and NDHR090013. |
| Product Distributed Qty | 20 units of NeuViz 16 CT Scanner Systems and 25 units of NeuViz Dual series |
| Reason For Recall | The four screws that secure the patient table top to the carrier pulled out and caused the table top to detach. This issue may affect NeuViz Dual and NeuViz 16 scanners. |
Event Detail
| Event Id | 63553 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Philips And Neusoft Medical Systems Co., Ltd. |
| City | Shenyang, Liaoning |
| State | Country | CN |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-10-09 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide Distribution including North Carolina, Ohio, Texas, and Puerto Rico. |
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