Reported May 28, 2014 · Terminated

syngo Imaging XS Syngo Imaging XS is a Picture Archiving and Communication System (PACS) intended to display, process,…

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 · 51 Valley Stream Pkwy · Malvern, PA · 19355

Is this the product you have?

  • syngo Imaging XS Syngo Imaging XS 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 Imaging XS also supports storage and archiving of Structured DICOM reports. Syngo Imaging XS optionally uses a variety of advanced postprocessing applications.
Lot codes and dates
  • material number10014063
  • with serial numbers

    64 of 64 codes

    • 1334
    • 1065
    • 1351
    • 1491
    • 1417
    • 1269
    • 1076
    • 1043
    • 1429
    • 1353
    • 1392
    • 1258
    • 1398
    • 1445
    • 1496
    • 1279
    • 1116
    • 1090
    • 1229
    • 1080
    • 1005
    • 1081
    • 1310
    • 1246
    • 1226
    • 1057
    • 1379
    • 1396
    • 1084
    • 1322
    • 1107
    • 1453
    • 1124
    • 1343
    • 1198
    • 1432
    • 1058
    • 1247
    • 1278
    • 1082
    • 1055
    • 1049
    • 1329
    • 1203
    • 1490
    • 1083
    • 1316
    • 1395
    • 1053
    • 1079
    • 1387
    • 1448
    • 1218
    • 1451
    • 1389
    • 1386
    • 1064
    • 1500
    • 1436
    • 1074
Amount recalled
64

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

  • Nationwide

Why it was recalled

A complaint reported that the archiving method at one customer site was changed from implicit to explicit, and the cleanup procedure enabled by the explicit archivingmethod may have deleted data from archive itself.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Dec 15, 2014 · Data as of Sep 19, 4:46 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.