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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 64737

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
October 05, 2012
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Siemens Medical Solutions USA, Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Siemens syngo WorkFlow SLR, Radiological Information System, Version VA31A SP1/SP2/SP3 The information system syngo(R) Workflow SLR is a digital radiology information system (RIS) with integrated modules for patient administration, examination, reporting, statistics and system administration, as well as multiple interfaces for patient registration, order entry, and external billing modules. It is not intended to treat disease or administer any medicinal substances or drugs. There is no contact between device and patient. syngo(R) Workflow SLR can be used as a separate RIS, interfacing to a Hospital Information System (HIS) or Picture Archiving and Communication Systems (PACS

Z-1105-2013
Recall number
Z-1105-2013
Initiated
October 05, 2012
Classification
Class II
Status
Terminated
Quantity
37

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Under certain conditions, when using the Search functionality, the potential exists for the wrong patient's Interactive Documents to display when viewing a signed report in the single patient view. This can occur when the Interactive Document is viewed or auto displayed, dismissed by the user, and then a different patient and signed exam is selected in single patient view. The Notes Viewer will

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

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Inspect official wording and provenance

Reason for recall

Under certain conditions, when using the Search functionality, the potential exists for the wrong patient's Interactive Documents to display when viewing a signed report in the single patient view. This can occur when the Interactive Document is viewed or auto displayed, dismissed by the user, and then a different patient and signed exam is selected in single patient view. The Notes Viewer will

Code information

Model numbers 10558922, 10558933 and 10558980 with software version VA31A SP1/SP2/SP3

Distribution pattern

Worldwide Distribution - USA including the states of AL, CA, CO, DC, DE, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MO, NC, NE, NH, NJ, NV, NY, OH, OR, PA, TN, TX, VA, WI, WV, and WY. and the countries of Canada and Australia.