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U.S. Department of Health and Human Services

Class 2 Device Recall Syngo Imaging

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 Class 2 Device Recall Syngo Imagingsee related information
Date Initiated by FirmJuly 25, 2017
Create DateJanuary 23, 2018
Recall Status1 Terminated 3 on July 23, 2018
Recall NumberZ-0405-2018
Recall Event ID 78911
510(K)NumberK081734 
Product Classification System, image processing, radiological - Product Code LLZ
ProductSyngo Imaging version V31 (model # 10014063) is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images, including digital mammography images. It supports the physician in diagnosis and treatment planning.
Code Information material 10014063 Serial numbers: 1334, 1065, 1417, 1043 1353,1491,1496, 1316, 1279, 1116, 1090, 1081, 1310, 1226, 1396, 1107, 1343, 1198, 1432, 1058, 1082 1055, 1049, 1329, 1490, 1083, 1053, 1079, 1218, 1451, 1386, 1064, 1500, 1005, 1322, 1074. Updated version 31 contains 2 improvements on front end for usability, such as query enhancements and calibration improvements
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc.
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information ContactAnastasia Sokolova
610-448-6461
Manufacturer Reason
for Recall		Siemens is releasing a letter to inform about potential data loss relevant to diagnosis.
FDA Determined
Cause 2		Software design
ActionSiemens sent an Urgent Customer Advisory Notice Letter to all customers. All versions before version VB36E_HF01 can be configured to behave like the version VB36E_HF01. Please contact your local CSE to configure this setting and to evaluate an eventual minor performance impact to the system.If the device has been sold and therefore no longer in your possession, please forward this notice to the new owner. We would also request that you inform us of the identity of the devices new owner where possible. Please observe this safety notice and comply with the corresponding measure until the update has been fully completed. For further questions, please call (610) 448-6461.
Quantity in Commerce36 units.
DistributionUSA (nationwide) Distribution to the states of: MA, CA, NC, WI, NY, NE, PA, AL, NJ, MO, MI, TX, MS, KS, LA, CT, MD, LA, CO, OK, MN and TN.
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 = LLZ
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