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Class 2 Device Recall NeuViz 16 MultiSlice CT Scanner System |
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Date Initiated by Firm |
March 24, 2016 |
Date Posted |
April 27, 2016 |
Recall Status1 |
Terminated 3 on November 23, 2016 |
Recall Number |
Z-1573-2016 |
Recall Event ID |
73741 |
510(K)Number |
K090173 K092742
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Product Classification |
System, x-ray, tomography, computed - Product Code JAK
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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. |
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 |
Recalling Firm/ Manufacturer |
Philips and Neusoft Medical Systems Co., Ltd. No. 2 Xiu xiu Street Hunnan; Sujiatun Shenyang China
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For Additional Information Contact |
Customer Service Center 281-4531205
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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
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FDA Determined Cause 2 |
Under Investigation by firm |
Action |
Affected 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 Commerce |
37 units |
Distribution |
NC, OH, NE, SC, TX, LA, PR, MO, FL, CT |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = JAK and Original Applicant = NEUSOFT MEDICAL SYSTEMS CO., LTD.
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