Device Recall NeuViz 64 Multislice CT Scanner System 의 리콜

Recall

71306

Class 2

Z-1693-2015

2014-03-08

2015-06-16

Terminated

United States

2016-12-05

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137271

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.

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 notified when the last A-plane compensator is replaced. 3. The Customer Information Letter has been sent to customers as a corrective action. The maximum exposure number of 5 US systems is 191830 seconds as of Apr.20, 2015, so the firm will monitor the data continuously and replace the A-plane compensators before the defined threshold. 4. Neusoft will replace all compensators that have exceeded the 300,000 seconds free of charge and will replace all compensators that fail during warranty and the compensators failed less than 300,000 seconds though out of warranty free of charge. You may proceed or continue with implementation of the CAP (subject to the conditions noted above) For further questions please call (281) 453-1205