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U.S. Department of Health and Human Services

Class 2 Device Recall Syngo Plaza VB10A

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  Class 2 Device Recall Syngo Plaza VB10A see related information
Date Initiated by Firm August 02, 2016
Date Posted September 14, 2016
Recall Status1 Terminated 3 on March 20, 2017
Recall Number Z-2794-2016
Recall Event ID 75125
510(K)Number K132532  
Product Classification picture archiving and communication system - Product Code LLZ
Product Syngo.Plaza VB 10 A, image processing system (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images.
Code Information Model Numbers: 10863171, 10863172, 10863173, 10592457  Serial Numbers:  100262,100389,100198,100258,100259,100538,100135,100133,100213,100214,100031,100032,100484,100362,100233,100140,100141,100142,100143,100144,100416,100105,100106,100109,100110,100111,100112,100113,100114,100115,100116,100117,100119,100120,100461,100457,100245,100447,100364,100314,100298,100299,100386,200277,100139,100027,100028,100300,100559,100440,100441,100197,100170,100025,100026,100084,100186,100189,100190,100191,100192,100195,100196,100550,100033,100034,100306,100307,100232,100449,100450,100185,100596,100256,100199,100188,100193,100194,100257,100226,100228,100425,100029,100030,100253,100203,100204,100132,100247,100248,100434,100215,100491,100495,100230,100221,100212,100539,100206
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information Contact Anastasia Sokolova
610-219-4834
Manufacturer Reason
for Recall		 Siemens is releasing a Customer Advisory Notice to explain meaning of a suffix o.p. that shows on some DICOM images on area, distance or perimeter values. This suffix stands for on projection and indicates that a shown measurement value may be different from the real value.
FDA Determined
Cause 2		 Error in labeling
Action Siemens mailed to customers on August 04, 2016 a Customer Advisory Notice that provided interpretations about the meaning of measurement values like area, distance and perimeter shown as "o.p." by the syngo.plaza.
Quantity in Commerce 101 Systems
Distribution Nationwide Distribution
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = LLZ and Original Applicant = SIEMENS AG HEALTHCARE
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