Reported Jan 31, 2018 · Terminated
Syngo Imaging version V31 (model # 10014063) is a Picture Archiving and Communication System (PACS) intended to…
Siemens Medical Solutions USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Medical Solutions USA, Inc. · 40 Liberty Blvd · Malvern, PA · 19355-1418
Is this the product you have?
- Syngo 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.
- Lot codes and dates
- material 10014063 Serial numbers1334, 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
- Amount recalled
- 36 units.
Where it was sold
Why it was recalled
Siemens is releasing a letter to inform about potential data loss relevant to diagnosis.
This product could cause temporary or reversible health problems — stop using it.
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