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U.S. Department of Health and Human Services

Class 2 Device Recall Syngo.plaza

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 Class 2 Device Recall Syngo.plazasee related information
Date Initiated by FirmJuly 06, 2015
Date PostedSeptember 02, 2015
Recall Status1 Terminated 3 on January 06, 2017
Recall NumberZ-2719-2015
Recall Event ID 71978
510(K)NumberK093612 
Product Classification System, image processing, radiological - Product Code LLZ
ProductSyngo.plaza; picture archiving and communications system Product Usage: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo.plaza also supports storage and archiving of DICOM Structured reports. In a comprehensive imaging syngo.plaza integrates Hospital/Radiology Information Systems (HIS/RIS) to enable customer specific workflows. Syngo.plaza optionally uses a variety of advanced postprocessing applications.
Code Information Model Number of device  10592457 with serial numbers: Serial 100544 100499 100600 100571 100263 200308 200309 200310 200311 200312 200313 200314 200315 200316 200317 200318 200319 200320 200321 200322 200323 200324 100146 200277 100177 100138 100174 100491 100492 100596 100198 100181 200251 200252 100301 100302 100539 
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Mail Code: 65-1A
Malvern PA 19355-1418
For Additional Information ContactCustomer Support
610-219-6300
Manufacturer Reason
for Recall		Potential issue leading to data loss and patient data mix-up
FDA Determined
Cause 2		Software design
ActionSiemens sent a Customer Information letter, dated July 6, 2015, to customers The letter identified the affected product, problem and action to be taken. The letter informed cusotmers about the Hotfix software update that was being released.
Quantity in Commerce37
DistributionUS Nationwide Distribution - in the states of CA, OR, FL, MO, NY, WA, MD, MA, NY, WI, KS, MN and PA.
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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