Recall Z-1693-2015 ยท JAK System, X-Ray, Tomography, Computed
Neusoft Medical System Co
Neusoft NeuViz 64 Multi-slice CT Scanner System
| Date | Jun 16, 2015 (initiated Mar 8, 2014) |
| Status | Terminated |
| Reason | The A-plane compensator is made of Teflon which will become fragile due to X-ray exposure passing through it. The thinnest part of the compensator is subject to radiation degradation and as a result has been found to fail prematurely. Failure is indicated by pin or ring artifact in the image |
| Root cause | Radiation Control for Health and Safety Act |
| Action | Neusoft planned action: 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2. Neusoft Medical Systems Co., Ltd will implement actions to monitor the exposures of the tube and when the exposure number is close to 300,000 seconds, the A-plane compensator will be replaced. The Food and Drug Administration (FDA) district office coordinator should be not |
| Quantity | 5 installed in US |
| Distribution | Worldwide Distribution - US Distribution including Puerto Rico and to the states of : IL, MA, TX and SC., and to the countries of : China, Malaysia, Lebanon, Ecuador, Egypt, United Arab Emirates,Kazashstan, Tunisia, Angola, Brazil, Uzbekistan, Lebanon, Cote D' ivoire, South Africa, Montenegro and Ta |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121792 | NEUVIZ 64 MULTI-SLICE CT SCANNER SYSTEM Neusoft Medical Systems Co., Ltd., Nov 16, 2012 |