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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 a potential malfunction when using syngo.plaza with software version VA20C_HF01. For datasets with distance measurements it can happen, that all images are not loaded to Viewer but no error message is displayed to user.
ProductSiemens syngo.plaza. Radiological image processing system
Quantity2
Distribution(USA) nationwide including the states of CA, FL, GA, MA, MN, MO, NJ, NY, OH, WA, and WI.
Initiated2012-02-24
Classified2012-07-26
Terminated2014-01-14
Recall numberZ-2078-2012
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-2078-2012).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/62462/

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