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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83056

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

Open FDA event record

Event summary

Timeline bucket
April 15, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Hitachi America, Ltd., Power Systems Division

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

PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system.

Z-1892-2019
Recall number
Z-1892-2019
Initiated
April 15, 2019
Classification
Class II
Status
Terminated
Quantity
3

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for a discrepant target position when using 3D3D matching mode in PIAS (Positioning Image Analysis System) software installed in the PROBEAT-V, proton therapy systems.

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

There is a potential for a discrepant target position when using 3D3D matching mode in PIAS (Positioning Image Analysis System) software installed in the PROBEAT-V, proton therapy systems.

Code information

2015B01, A01, A02

Distribution pattern

Distributed to accounts located in AZ, MN, and TN. Foreign distribution to Japan.