ModerateClass IITerminated

FDA Devices recall · Reported August 1, 2012

NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography X-ray system, and has a Part number 989605858501. The device is labeled in part: "NeusoftNeuViz16 MULTI-SLICE CT SCANNER SYSTEMMANUFACTURED FOR NEUSOFT MEDICAL SYSTEMS CO., LTDMANUFACTURED BY PHILIPS AND NEUSOFT MEDICAL SYSTEMS CO., LTDADDRESS: NEUSOFT PARK, HUNNAN INDUSTRIAL AREA, SHENYANGCHINA***".

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on August 1, 2012. Severity: Moderate. Recall number: Z-2083-2012.

Q: Where was the recalled product distributed?

Distribution: Nationwide Distribution -- North Carolina, Ohio, and Texas..

Q: 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.

One of the four screws that secure the Oil-accumulator to the X-Ray Tube pulled out in the NeuViz 16 CT scanner, which caused the Oil-accumulator to detach.

Recall #: Z-2083-2012
Affected scope: 15 units distributed in the US
Initiated: June 8, 2012

Compiled from official public sources by the publisher. · Updated September 2026

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Philips And Neusoft Medical Systems Co., Ltd. recalled NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography X-ray system, and has a … - a moderate-severity action.

NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography X-ray system, and has a … was recalled by Philips And Neusoft Medical Systems Co., Ltd. in August 1, 2012. Reason: One of the four screws that secure the Oil-accumulator to the X-Ray Tube pulled out in the NeuViz 16 CT scann…. Check the official notice for the remedy. Verify recall #Z-2083-2012 with the FDA Devices before acting.

The recall

Philips And Neusoft Medical Systems Co., Ltd. issued this moderate-severity FDA Devices recall-One of the four screws that secure the Oil-accumulator to the X-Ray Tube pulled out in the NeuViz 16 CT scann….

Moderate
severity level: 15 units
affected scope: Class II
classification: August 1, 2012
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-2083-2012 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) 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, 6 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.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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.

Product description

NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography X-ray system, and has a Part number 989605858501. The device is labeled in part: "***Neusoft***NeuViz16 MULTI-SLICE CT SCANNER SYSTEM***MANUFACTURED FOR NEUSOFT MEDICAL SYSTEMS CO., LTD***MANUFACTURED BY PHILIPS AND NEUSOFT MEDICAL SYSTEMS CO., LTD***ADDRESS: NEUSOFT PARK, HUNNAN INDUSTRIAL AREA, SHENYANG***CHINA***".

Reason for recall

One of the four screws that secure the Oil-accumulator to the X-Ray Tube pulled out in the NeuViz 16 CT scanner, which caused the Oil-accumulator to detach.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	Z-2083-2012
Date reported	August 1, 2012
Date initiated	June 8, 2012
Recalling firm	Philips And Neusoft Medical Systems Co., Ltd.
Firm location	Shenyang, Liaoning
Affected scope	15 units distributed in the US
Distribution	Nationwide Distribution -- North Carolina, Ohio, and Texas.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

15 units distributed in the US units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) -

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-2083-2012) 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? ▼

Why was this product recalled? ▼

One of the four screws that secure the Oil-accumulator to the X-Ray Tube pulled out in the NeuViz 16 CT scanner, which caused the Oil-accumulator to detach.

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on August 1, 2012. Severity: Moderate. Recall number: Z-2083-2012.

Where was the recalled product distributed? ▼

Distribution: Nationwide Distribution -- North Carolina, Ohio, and Texas..

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.

Nationwide recalls with similar severity or category timing

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This recall: FDA Devices, reported August 1, 2012. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026