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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 69825

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

Open FDA event record

Event summary

Timeline bucket
December 02, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK

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

VERO Linear Accelerator System, Model Number MHI-TM2000, MHI Identifier M101-14021, Software Version: 3.1, 3.2 and 3.5.0.

Z-0821-2015
Recall number
Z-0821-2015
Initiated
December 02, 2014
Classification
Class II
Status
Terminated
Quantity
Domestic: 4 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
Software Anomaly

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

Software Anomaly. The VERO MHI-TM2000 Operator Console may provide Patient Positioning System (ExacTrac) with Image Angle Information Used for the 1st Port Image, for a subsequent port image fusion. As the result, ExacTrac may display a Digitally Reconstructed Radiograph (DRR) image taken from the angle for the 1st port image fusion, rather than the one taken from the angle for the intended port

Code information

Serial Numbers: 201902, 203901, 203919, and 203924 (US only)

Distribution pattern

US Distribution to the states of NY, FL, TX and OH.