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Recall Observatory FDA recall evidence

Device product

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.

Z-0405-2018

July 25, 2017

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc.
Event
Event 78911
Status
Terminated
Classification
Class II
Quantity
36 units.
Official record key
device-enforcement:Z-0405-2018

Official wording

Reason: Siemens is releasing a letter to inform about potential data loss relevant to diagnosis.

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

Distribution pattern: USA (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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Siemens is releasing a letter to inform about potential data loss relevant to diagnosis.