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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84957

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

Open FDA event record

Event summary

Timeline bucket
February 06, 2020
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

Monitor for the Functional Imaging System for Magnetic Resonance Imaging System

Z-1440-2020
Recall number
Z-1440-2020
Initiated
February 06, 2020
Classification
Class II
Status
Terminated
Recalling firm
Invivo Corporation
Quantity
75

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Insufficient shielding of Philips SensaVue DVI Adapter for computer monitor.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Insufficient shielding of Philips SensaVue DVI Adapter for computer monitor.

Code information

9896-032-0815 SensaVue HD and 9896-032-0872x SensaVue fMRI

Distribution pattern

U.S Distribution: AK, AL, CA, CO, FL, IL, IN, KY, MA, MI, NY, OH, OR, PA, TN, TX and WV. *** Foreign: Australia, Canada, France, United Kingdom, Italy, Japan, Netherlands, Saudi Arabia, India and Thailand.