| Class 2 Device Recall Syngo Plaza VB10A |  |
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
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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
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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 |
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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 = LLZ
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