CLASS II Device recall · Reported 1 May 2013 · FDA Enforcement Report
NeuViz 16 Multi-Slice CT Scanner System recalled
Philips And Neusoft Medical Systems is recalling NeuViz 16 Multi-Slice CT Scanner System, distributed nationwide in the US. The recall was initiated on 4 Mar 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1165-2013
- FDA event ID
- 64783
- Recalling firm
- Philips And Neusoft Medical Systems, Shenyang, Liaoning
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Mar 2013
- FDA classified
- 23 Apr 2013
- Reported
- 1 May 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 4 Mar 2013 | Recall initiated by company | |
| 23 Apr 2013 | Classified by FDA | +50 days |
| 1 May 2013 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
User error of the NeuViz 16 or NeuViz Dual may cause personnel injuries. There was a report where a finger was pinched when the table was moved backward while the tabletop was controlled by another person from the gantry left control panel.
Product as listed by the FDA
NeuViz 16 Multi-Slice CT Scanner System, Part number (PN): 989605858501, Model: NeuViz 16. This is a computed X-ray, Tomography system. 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 acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from the same axial plane taken at different angles. The system is suitable for all patients
Where it was distributed
Nationwide distribution: USA including states of: California, Connecticut, North Carolina, Nebraska, Ohio, South Carolina, Texas, and Puerto Rico.
Nationwide CaliforniaConnecticutNorth CarolinaNebraskaOhioPuerto RicoSouth CarolinaTexas
Questions about this recall
Why was it recalled?
User error of the NeuViz 16 or NeuViz Dual may cause personnel injuries. There was a report where a finger was pinched when the table was moved backward while the tabletop was controlled by another person from the gantry left control panel.
Which lots are affected?
Serial numbers: N16E090002, N16E090003, N16E090004, N16E090007, N16E090008, N16E090010, N16E100015, N16E100017, N16E100023, N16E110016, N16E110023, N16E110026, N16E110027, N16E110040, N16E110053, N16E120016, N16E120020, N16E120022, N16E120023, N16E120024, N16E120052, N16E120053, and N16E130002.
Where was it sold?
Nationwide distribution: USA including states of: California, Connecticut, North Carolina, Nebraska, Ohio, South Carolina, Texas, and Puerto Rico.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 64783| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | NeuViz Dual series CT Scanner System recalled | Philips And Neusoft Medical Systems | Other | Nationwide |
More recalls from Philips And Neusoft Medical Systems
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | NeuViz 16 Multi-Slice CT Scanner System PN recalled | Philips and Neusoft Medical Systems | Device Malfunction | 10 states |
| Device | CLASS II | NeuViz Dual series CT Scanner System recalled | Philips And Neusoft Medical Systems | Other | Nationwide |
| Device | CLASS II | NeuViz 16 Multi-Sliced CT Scanner System recalled | Philips And Neusoft Medical Systems | Other | Nationwide |
| Device | CLASS II | NeuViz 16 Multi-Slice CT Scanner System is a computed recalled | Philips And Neusoft Medical Systems | Other | Nationwide |
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