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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 73421

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

Open FDA event record

Event summary

Timeline bucket
February 10, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Deerfield Imaging

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

Intra operative MRI Systems: Neuro II-SE , Neuro III-SV, iMRI 1.5T A, and iMRI 3T S. Indicated for use as a magnetic resonance diagnostic device (MRDD).

Z-1098-2016
Recall number
Z-1098-2016
Initiated
February 10, 2016
Classification
Class II
Status
Terminated
Recalling firm
Deerfield Imaging
Quantity
35 USA, 14 OUS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Emergency helium venting lines (i.e. quench lines) may not have been properly installed.

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

Emergency helium venting lines (i.e. quench lines) may not have been properly installed.

Code information

70036, 10076-21, M00004, 10073-01, 23529, 40481, M00152, M00005, 30445, M00169, 060014, 10043-00, 30823, 10004680, 10050-01, 40662, 30935, 31084, 31203, 10002221, 40510, 40613, 30719, 31046, 30910, 30832, 30623, 31213, 10004152, 10072-01, 31250, 40815, 31049, 30068, 40412, M0038, M00106, M00367, 10035-01, 40475, 40495, 10007498, 10005946, 40263, 40688, 10058-00, 40619, 31085, and 10005639.

Distribution pattern

Worldwide Distribution -- US, including the states of CA, CT, FL, GA, IL, IN, MD, MA, MN, MO, NH, NC, OH, OR, PA, TX, UT, VA, and WI; and ,countries of CHINA, CANADA, AUSTRALIA, FRANCE, JAPAN, and GERMANY.