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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68353

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

Open FDA event record

Event summary

Timeline bucket
May 22, 2014
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Siemens Healthcare Diagnostics 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 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,

Z-2071-2014
Recall number
Z-2071-2014
Initiated
May 22, 2014
Classification
Class III
Status
Terminated
Quantity
6 systems

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
RAPIDComm¿ 5.0 Screen Layout will display incorrect test names

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

RAPIDComm¿ 5.0 Screen Layout will display incorrect test names

Code information

Serial Numbers: 4387, 3734, 4177, 4149, 3074, 4194

Distribution pattern

Worldwide Distribution - US including the states of OR and PA., and the countries of Denmark and UK.