RegWardenFDA facility compliance records
Recall

Class III — Siemens Healthcare Diagnostics Inc

Recalling firmSIEMENS HEALTHCARE DIAGNOSTICS INC.
Registered facilityView this company's 12 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass III
StatusTerminated
ReasonRAPIDComm® 5.0 Screen Layout will display incorrect test names
ProductSiemens RAPIDComm® Data Management System. The RAPIDComm® Data Management System manages the process of sending and receiving data from Siemens POC devices and hospital systems located in the hospital network,
Quantity6 systems
DistributionWorldwide Distribution - US including the states of OR and PA., and the countries of Denmark and UK.
Initiated2014-05-22
Classified2014-07-17
Terminated2015-05-26
Recall numberZ-2071-2014
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 III recall — Siemens Healthcare Diagnostics Inc (Z-2071-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/68353/

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