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Recall

Class II — Siemens Medical Solutions USA, Inc

Recalling firmSIEMENS MEDICAL SOLUTIONS USA, INC.
Registered facilityView this company's 9 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusTerminated
ReasonSiemens became aware of an unintended behavior when using syngo.plaza. In syngo.plaza within the online "Short Time Storage" (STS), some studies are marked with an archived icon, however, the entry in the Archive Database referring to the physical file may be missing.
ProductSiemens syngo.plaza radiological image processing system.
Quantity11
DistributionNationwide Distribution including the states of MO, FL, MA, NY, WI, GA, CA and WA.
Initiated2012-06-06
Classified2012-10-11
Terminated2013-04-13
Recall numberZ-0048-2013
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Siemens Medical Solutions USA, Inc (Z-0048-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/63045/

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