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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 74064

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

Open FDA event record

Event summary

Timeline bucket
May 06, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Invivo Corporation

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

Invivo Sentinelle Venguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE 1.5T/3T MRI Systems.

Z-2688-2016
Recall number
Z-2688-2016
Initiated
May 06, 2016
Classification
Class II
Status
Terminated
Recalling firm
Invivo Corporation
Quantity
3

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A diode was inadvertently not assembled into the system, which may result in coil overheating

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A diode was inadvertently not assembled into the system, which may result in coil overheating

Code information

Model #: 9896-032-14382; Serial #: 13 (production order 301128446), 14 (production order 301153586), and 15 (production order 301153587).

Distribution pattern

WI