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U.S. Department of Health and Human Services

Class 2 Device Recall NeuViz 16 MultiSlice CT Scanner System

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 Class 2 Device Recall NeuViz 16 MultiSlice CT Scanner Systemsee related information
Date Initiated by FirmMarch 24, 2016
Date PostedApril 27, 2016
Recall Status1 Terminated 3 on November 23, 2016
Recall NumberZ-1573-2016
Recall Event ID 73741
510(K)NumberK090173 K092742 
Product Classification System, x-ray, tomography, computed - Product Code JAK
ProductNeuViz 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.
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
FEI Number 3003575350
Recalling Firm/
Manufacturer		 Philips and Neusoft Medical Systems Co., Ltd.
No. 2 Xiu xiu Street
Hunnan; Sujiatun
Shenyang China
For Additional Information ContactCustomer Service Center
281-4531205
Manufacturer Reason
for Recall		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
FDA Determined
Cause 2		Under Investigation by firm
ActionAffected consignees will be notified of the recall via letter on March 24, 2016. Mandatory Field Change Order and FCO kits will be released to all affected systems in June, 2016.
Quantity in Commerce37 units
DistributionNC, OH, NE, SC, TX, LA, PR, MO, FL, CT
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JAK
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