Reported May 1, 2013 · Terminated
NeuViz 16 Multi-Slice CT Scanner System, Part number (PN): 989605858501, Model: NeuViz 16. This is a computed X-ray,…
Philips And Neusoft Medical Systems Co., Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips And Neusoft Medical Systems Co., Ltd. · 16 Century Road, Neusoft Park, · Shenyang, Liaoning · N/A
Is this the product you have?
- NeuViz 16 Multi-Slice CT Scanner System
- Part number (PN)989605858501
- ModelNeuViz 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
- Lot codes and dates
- Serial numbers
N16E090002N16E090003N16E090004N16E090007N16E090008N16E090010N16E100015N16E100017N16E100023N16E110016N16E110023N16E110026N16E110027N16E110040N16E110053N16E120016N16E120020N16E120022N16E120023N16E120024N16E120052N16E120053and N16E130002
- Serial numbers
- Amount recalled
- 23 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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