Reported Sep 9, 2015 · Terminated

Syngo.plaza; picture archiving and communications system Product Usage: Syngo.plaza is a Picture Archiving and…

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.plaza; picture archiving
  • and communications system Product UsageSyngo.plaza 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.plaza also supports storage and archiving of DICOM Structured reports. In a comprehensive imaging syngo.plaza integrates Hospital/Radiology Information Systems (HIS/RIS) to enable customer specific workflows. Syngo.plaza optionally uses a variety of advanced postprocessing applications
Lot codes and dates
  • Model Number
  • of device 10592457 with serial numbersSerial
    • 100544
    • 100499
    • 100600
    • 100571
    • 100263
    • 200308
    • 200309
    • 200310
    • 200311
    • 200312
    • 200313
    • 200314
    • 200315
    • 200316
    • 200317
    • 200318
    • 200319
    • 200320
    • 200321
    • 200322
    • 200323
    • 200324
    • 100146
    • 200277
    • 100177
    • 100138
    • 100174
    • 100491
    • 100492
    • 100596
    • 100198
    • 100181
    • 200251
    • 200252
    • 100301
    • 100302
    • 100539
Amount recalled
37

Where it was sold

Why it was recalled

Potential issue leading to data loss and patient data mix-up

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.

Free recall alerts

Get alerted about new Siemens Medical Solutions USA, Inc. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Jan 6, 2017 · Data as of Sep 19, 4:49 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.