Siemens Medical Solutions USA, Inc. syngo US Workplace Picture Archiving and Communication System, software version 2.0, Siemens Medical Solutions, Inc., Mountain View, CA 94043 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
syngo US Workplace Picture Archiving and Communication System, software version 2.0, Siemens Medical Solutions, Inc., Mountain View, CA 94043
Brand
Siemens Medical Solutions USA, Inc.
Lot Codes / Batch Numbers
Material number: 10035829, serial numbers: 250576, 260044, 260049, 260016, 250533, 250548, 250544, 250545, 250591, 250595, 250617, 700464562, 700465913, 700465914, 250565, 250557, and 250556.
Products Sold
Material number: 10035829, serial numbers: 250576, 260044, 260049, 260016, 250533, 250548, 250544, 250545, 250591, 250595, 250617, 700464562, 700465913, 700465914, 250565, 250557, and 250556.
Siemens Medical Solutions USA, Inc. is recalling syngo US Workplace Picture Archiving and Communication System, software version 2.0, Siemens Medica due to Inaccurate results: A software bug may cause inaccurate wall motion abnormality scoring results to be displayed.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Inaccurate results: A software bug may cause inaccurate wall motion abnormality scoring results to be displayed.
Recommended Action
Per FDA guidance
Siemens Medical Solutions sent an Urgent Medical Device Notification letter, dated November 2007, to its consignees. The letter described action required by users, and that Siemens will contact the user with a new software version correcting this error. A field correction to update software is planned to be underway, designated to start on 12/21/2007, and the correction is expected to be completed within 45 days.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN, NJ
Page updated: Jan 10, 2026