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U.S. Department of Health and Human Services

Class 2 Device Recall Syngo.via

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  Class 2 Device Recall Syngo.via see related information
Date Initiated by Firm June 23, 2016
Create Date July 20, 2016
Recall Status1 Terminated 3 on February 20, 2020
Recall Number Z-2245-2016
Recall Event ID 74620
510(K)Number K092519  K123375  
Product Classification System, image processing, radiological - Product Code LLZ
Product Syngo.via, picture archiving and communications system software controlled.

Intended to be used for viewing, manipulation, communication, and storage of medical images.
Code Information 310289,130542,130322,310149,130325,221063,310168,101762,221048,221096,220783,310195,130451,400031,130292,310114,220846,130269,130163,130402,130826,221051,102336,310282,220888,10007,221052,221049,130518,221002,221091,220915,130520,130472,100469,310249,130122,100013,130378,310188,102453,310079,310080,130240,130382,220985,310171,220879,220995, and 310268.
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information Contact Anastasia Sokolova
610-448-6478
Manufacturer Reason
for Recall		 Incorrect values for the volume calculation. Software update VB30B via Update Instructions SY018/16/P to resolve software errors.
FDA Determined
Cause 2		 Software design
Action Siemens released and mailed to customers a notice with software update VB30B instructions via update instruction SY018/16/P for customers to follow until the update can be made. The letter also described the software issues involved; and asked customers to include the letter in the operator's manual until the update is performed. Customers are to ensure that all necessary personnel are aware of the situation.
Quantity in Commerce 50 units
Distribution Nationwide Distribution -- AR, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, ND, NE, NJ, NM, NV, NY, OH, OK, PA, SC, TX, and UT.
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
510(K)s with Product Code = LLZ and Original Applicant = SIEMENS AG, MEDICAL SOLUTIONS
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