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.
Enforcement
- Recall Number
- Z-1573-2016
- Event ID
- 73741
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Philips and Neusoft Medical Systems Co., Ltd.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 4, 2016
- Initiation Date
- March 24, 2016
- Classification Date
- April 27, 2016
- Termination Date
- November 23, 2016
- Address
- No. 2 Xiu xiu Street, Hunnan; Sujiatun, Shenyang, N/A, N/A, China
Description
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.
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
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
NC, OH, NE, SC, TX, LA, PR, MO, FL, CT
37 units