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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80071

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

Open FDA event record

Event summary

Timeline bucket
February 21, 2018
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

Biograph Horizon, PET/CT System using VJ10A, VJ10B, VJ20A scanners that provide registration and fusion of high resolution physiologic and anatomic information.

Z-1930-2018
Recall number
Z-1930-2018
Initiated
February 21, 2018
Classification
Class II
Status
Terminated
Quantity
14 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
issue caused by a firmware

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design (manufacturing process)

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Possibility that the Biograph Horizon systems performing CT retrospective cardiac gating or PET cardiac gating examinations may experience a waveform sampling issue caused by a firmware change within the Universal Physiological Measurement Module.

Code information

Code No. 10532746, 10532748

Distribution pattern

Domestic distribution to . International distribution to Finland, France, France, Iran, Ireland, Italy, Japan, Japan, Netherlands.