Severity
Moderate
FDA Devices recall · Reported December 12, 2012
The four screws that secure the patient table top to the carrier pulled out and caused the table top to detach. This issue may affect NeuViz Dual and NeuViz 16 scanners.
Philips And Neusoft Medical Systems Co., Ltd. recalled NeuViz 16 Multi-Sliced CT Scanner System, part number 989605858501. NeuViz Dual series C… - a moderate-severity action.
NeuViz 16 Multi-Sliced CT Scanner System, part number 989605858501. NeuViz Dual series C… was recalled by Philips And Neusoft Medical Systems Co., Ltd. in December 12, 2012. Reason: The four screws that secure the patient table top to the carrier pulled out and caused the table top to detac…. Check the official notice for the remedy. Verify recall #Z-0466-2013 with the FDA Devices before acting.
The recall
Philips And Neusoft Medical Systems Co., Ltd. issued this moderate-severity FDA Devices recall-The four screws that secure the patient table top to the carrier pulled out and caused the table top to detac….
Sourced from official FDA Devices enforcement records. Verify recall #Z-0466-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-0466-2013) was formally reported on December 12, 2012, with the manufacturer initiating the action on October 18, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Philips And Neusoft Medical Systems Co., Ltd. is listed as the recalling firm, operating out of Shenyang, Liaoning, N/A. Federal records list the affected scope as 20 units of NeuViz 16 CT Scanner Systems and 25 units of NeuViz Dual series.
The documented reason for this recall is: The four screws that secure the patient table top to the carrier pulled out and caused the table top to detach. This issue may affect NeuViz Dual and NeuViz 16 scanners. Distribution data in the federal record shows the product reached: Nationwide Distribution including North Carolina, Ohio, Texas, and Puerto Rico.. 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.
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.
Severity
Moderate
Affected scope
20 units of NeuViz 16 CT Scanner Systems and 25 units of NeuViz Dual series
Related Recalls
6
3 from same agency
NeuViz 16 Multi-Sliced CT Scanner System, part number 989605858501. NeuViz Dual series CT Scanner System, part number 989605651321 The NeuViz 16 CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously.
The four screws that secure the patient table top to the carrier pulled out and caused the table top to detach. This issue may affect NeuViz Dual and NeuViz 16 scanners.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0466-2013 |
| Date reported | December 12, 2012 |
| Date initiated | October 18, 2012 |
| Recalling firm | Philips And Neusoft Medical Systems Co., Ltd. |
| Firm location | Shenyang, Liaoning, N/A |
| Affected scope | 20 units of NeuViz 16 CT Scanner Systems and 25 units of NeuViz Dual series |
| Distribution | Nationwide Distribution including North Carolina, Ohio, Texas, and Puerto Rico. |
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.
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.
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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 December 12, 2012. 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.