Recall Z-0466-2013 ยท JAK System, X-Ray, Tomography, Computed
Philips And Neusoft Medical Systems Co., Ltd.
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.
| Date | Dec 4, 2012 (initiated Oct 18, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | Philips and Neusoft Medical Systems Co., Ltd. sent an Urgent Device Correction NeuViz Dual, NeuViz 16 letter, dated Oct. 18, 2012, to all affected US customers and distributors. The letter described the product, problem, and actions to be taken by the customers. Customers are advised to: 1. Have a mechanic check the patient table top screws fixing. Detailed instructions are attached as Annex with the letter. 2. If it is found that table top screws are improperly assembled, stop using the product and contact local Service personnel for repair. Philips and Neusoft Medical Systems Co., Ltd |
| Quantity | 20 units of NeuViz 16 CT Scanner Systems and 25 units of NeuViz Dual series |
| Distribution | Nationwide Distribution including North Carolina, Ohio, Texas, and Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062451 | NEUVIZ DUAL MULTI-SLICE CT SCANNER SYSTEM Neusoft Medical Systems Co., Ltd., Sep 28, 2006 |
| K071308 | MODIFICATION TO NEUVIZ DUAL MULTI-SLICE CT SCANNER SYSTEM Neusoft Medical Systems Co., Ltd., Aug 16, 2007 |
| K090173 | NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM Neusoft Medical Systems Co., Ltd., Feb 5, 2009 |
| K092742 | NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM Neusoft Medical Systems Co., Ltd., Sep 22, 2009 |