Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported June 24, 2015
Neusoft NeuViz 64 Multi-slice CT Scanner System
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 degradat…
Neusoft Medical System Co recalled Neusoft NeuViz 64 Multi-slice CT Scanner System - a moderate-severity action.
Neusoft NeuViz 64 Multi-slice CT Scanner System was recalled by Neusoft Medical System Co in June 24, 2015. Reason: The A-plane compensator is made of Teflon which will become fragile due to X-ray exposure passing through it.…. Check the official notice for the remedy. Verify recall #Z-1693-2015 with the FDA Devices before acting.
The recall
Neusoft Medical System Co issued this moderate-severity FDA Devices recall-The A-plane compensator is made of Teflon which will become fragile due to X-ray exposure passing through it.….
- Moderate
- severity level
- Class II
- classification
- June 24, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1693-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1693-2015) was formally reported on June 24, 2015, with the manufacturer initiating the action on March 8, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Neusoft Medical System Co is listed as the recalling firm, operating out of Houston, TX. Federal records list the affected scope as 5 installed in US.
The documented reason for this recall is: 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 fa… Distribution data in the federal record shows the product reached: 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, Ang…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
5 installed in US
Related Recalls
6
3 from same agency
Product description
Neusoft NeuViz 64 Multi-slice CT Scanner System
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
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1693-2015 |
| Date reported | June 24, 2015 |
| Date initiated | March 8, 2014 |
| Recalling firm | Neusoft Medical System Co |
| Firm location | Houston, TX |
| Affected scope | 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, Uzbekis… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1693-2015) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Neusoft NeuViz 64 Multi-slice CT Scanner System. Recalled by Neusoft Medical System Co. Units affected: 5 installed in US.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 24, 2015. Severity: Moderate. Recall number: Z-1693-2015.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1693-2015) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported June 24, 2015. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.