Z-1693-2015Class II

Neusoft NeuViz 64 Multi-slice CT Scanner System

Name: Z-1693-2015 Neusoft NeuViz 64 Multi-slice CT Scanner System
Creator: Neusoft Medical System Co
Published: 2014-03-08
License: https://open.fda.gov/license/

Neusoft Medical System Co / initiated 2014-03-08 / Terminated

FDA source

Neusoft Medical System Co began a recall of Neusoft NeuViz 64 Multi-slice CT Scanner System on 2014-03-08. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1693-2015
Classification: Class II
Status: Terminated
Initiated: 2014-03-08
Posted: 2015-06-16
Terminated: 2016-12-05
Recalling firm: Neusoft Medical System Co
Product: Neusoft NeuViz 64 Multi-slice CT Scanner System
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: 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
FDA 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 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
Quantity in commerce: 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 Tajikistan.
Product codes and lots: NeuViz 16/64 Series

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1693-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1693-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-24	2015-06-16

Product code JAK

K121792Class IINeuviz 64 Multi-Slice CT Scanner SystemNeusoft Medical Systems Co., Ltd. / cleared 2012-11-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)