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Recall Observatory FDA recall evidence

Device product

NeuViz 16 Multi-Slice CT Scanner System PN: 989605858501 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.

Z-1573-2016

March 24, 2016

Class II

Product summary

Firm
Philips and Neusoft Medical Systems Co., Ltd.
Event
Event 73741
Status
Terminated
Classification
Class II
Quantity
37 units
Official record key
device-enforcement:Z-1573-2016

Official wording

Reason: 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

Code information: Serial Numbers: N16E090002, N16E090003, N16E090007, N16E090008, N16E090010, N16E100023, N16E110023, N16E110026, N16E120016, N16E120023, N16E120052, N16E120053, N16E130012, N16E130038, N16E130045, N16E140008, N16E140007, N16E140012, N16E140017, N16E140020, N16E140029, N16E140056, N16E140057, N16E140058, N16E150004, N16E150014, N16E150013, N16E150015, N16E150025, N16E150024, N16E150027, N16E150038, N16E150039, N16E150040, N16E100017, N16E140030 and N16E140031

Distribution pattern: NC, OH, NE, SC, TX, LA, PR, MO, FL, CT

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software, the clipboard used for copying and pasting images is not cleared between patients. If the operator fails to