Recall Z-1166-2013 ยท JAK System, X-Ray, Tomography, Computed
Philips And Neusoft Medical Systems Co., Ltd.
NeuViz Dual series CT Scanner System, Part number (PN): 989605651321. This is a computed X-ray, Tomography system. NeuViz Dual Multi-slice CT Scanner System is intended to produce cross-section images of head and body by computer reconstruction of X-ray transmission data taken at different angles.
| Date | Apr 23, 2013 (initiated Mar 4, 2013) |
| Status | Terminated |
| Reason | User error of the NeuViz 16 or NeuViz Dual may cause personnel injuries. There was a report where a finger was pinched when the table was moved backward while the tabletop was controlled by another person from the gantry left control panel. |
| Root cause | Use error |
| Action | The firm, Neusoft Medical Systems Co., Ltd., sent an "URGENT DEVICE CORRECTION" NeuViz Dual and NeuViz 16 letter, dated Mar. 4, 2013, to their US consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to review this information with all members of their staff and retain a copy of the letter with the equipment Instruction For Use. Customers with questions should contact the Service Support Department by email to nms-service@neusoft.com |
| Quantity | 25 units |
| Distribution | Nationwide distribution: USA including states of: California, Connecticut, North Carolina, Nebraska, Ohio, South Carolina, Texas, and Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071308 | MODIFICATION TO NEUVIZ DUAL MULTI-SLICE CT SCANNER SYSTEM Neusoft Medical Systems Co., Ltd., Aug 16, 2007 |