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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens Syngo Dynamics

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 Class 2 Device Recall Siemens Syngo Dynamics see related information
Date Posted May 13, 2014
Recall Status1 Terminated on December 15, 2014
Recall Number Z-1613-2014
Recall Event ID 67960
510(K)Number K023772  K102150 
Product Classification System, image processing, radiological - Product Code LLZ
Product Syngo Dynamics v9.5 system. A Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation.
Code Information model numbers: 10091805, 10091806, 10091807, 10091673 with serial numbers: 85170
85250
85188
85191
85198
85151
85165
85241
85130
85163
85019
85287
85298
85202
85168
85068
85206
85280
85235
85195
85194
85123
85199
85364
85282
85275
85115
85062
85067
85080
85216
85218
85177
85242
85248
85237
85284
85329
85259
85279
85230
85192
85277
85278
85178
85220
85157
85114
85268
85134
Recalling Firm/
Manufacturer
Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355
610-219-6300
For Additional Information Contact Customer Support
610-219-6300
Manufacturer Reason
for Recall
Systems with the affected serial number are experiencing a software error which may lead to incorrect patient demographics display.
FDA Determined
Cause 2
Software design
Action Siemens sent a Recall Notification letter dated March 26, 2014 to affected customers. The letter identified the affected product, problem and actions to be taken. Siemens is preparing a Service Patch modification that would be performed to resolve the software issue.
Quantity in Commerce 50
Distribution US Nationwide Distribution in the states of AR, CA, CT, GA, IA, IL, KS, MA, MI, MN, NJ, NM, NY, OH, OR, PA, TX, TN, TX, WA, WI, and WV.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = ACUSON CORP.
510(K)s with Product Code = LLZ and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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