Reported May 4, 2016 · Terminated
NeuViz 16 Multi-Slice CT Scanner System PN: 989605858501 a whole body computed tomography X-ray system featuring a…
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. · No. 2 Xiu xiu Street · Shenyang, N/A · N/A
Is this the product you have?
- NeuViz 16
- Multi-Slice CT Scanner System PN989605858501 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
- Lot codes and dates
- Serial Numbers
N16E090002N16E090003N16E090007N16E090008N16E090010N16E100023N16E110023N16E110026N16E120016N16E120023N16E120052N16E120053N16E130012N16E130038N16E130045N16E140008N16E140007N16E140012N16E140017N16E140020N16E140029N16E140056N16E140057N16E140058N16E150004N16E150014N16E150013N16E150015N16E150025N16E150024N16E150027N16E150038N16E150039N16E150040N16E100017N16E140030 and N16E140031
- Serial Numbers
- Amount recalled
- 37 units
Where it was sold
Why it was recalled
The following issues are found in NeuViz 16 systems with software version 1.1.4.21425 and version 1.1.4.21426: 1) During the filming operation on MX 16-slice console software, the clipboard used for copying and pasting images is not cleared between patients. If the operator fails to copy the current patient's images before pasting, a previous patient's image may be present in the clipboard and be
This product could cause temporary or reversible health problems — stop using it.
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