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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68758

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

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Event summary

Timeline bucket
August 18, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Hitachi Medical Systems America 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

Hitachi Echelon Oval MRI system is a diagnostic imaging device (one unit per package) and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation.

Z-2564-2014
Recall number
Z-2564-2014
Initiated
August 18, 2014
Classification
Class II
Status
Terminated
Quantity
39 systems

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Gradient Coil was found to have a failure mode that allowed it to overheat and become a burn hazard.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Gradient Coil was found to have a failure mode that allowed it to overheat and become a burn hazard.

Code information

Product Codes: Y001, Y002, Y003, Y004, Y005, Y006, Y007, Y008, Y009, Y010, Y011, Y012, Y014, Y015, Y016, Y101, Y102, Y103, Y105, and Y951. To be updated as firm submits information.

Distribution pattern

Worldwide Distribution: US (nationwide) including states of: CA, DE, FL, ID, KS, KY, MD, MS, NY, OH, and WY; countries of: Japan, Brazil, France, Germany, and Kyrgyzstan.