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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79816

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

Open FDA event record

Event summary

Timeline bucket
April 04, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Deerfield Imaging, 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

IMRIS IMRI 1.5T AND 3T S System Product Usage: The IMRIS intraoperative MRI systems are traditional MRI systems that have been suspended on an overhead rail system. and is designated to operative inside an RF shielded room to facilitate intraoperative and multi room use.

Z-1645-2018
Recall number
Z-1645-2018
Initiated
April 04, 2018
Classification
Class II
Status
Terminated
Recalling firm
Deerfield Imaging, Inc.
Quantity
10 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The DC power to the IFOSS collision detector control panel at your facility is being adversely affected by the magnetic field. Our investigation shows the magnetic field is causing the IFOSS control panel to malfunction.

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 DC power to the IFOSS collision detector control panel at your facility is being adversely affected by the magnetic field. Our investigation shows the magnetic field is causing the IFOSS control panel to malfunction.

Code information

Serial Numbers: 10111-00, 10073-01, 10043-01, 10097-01, 10006-11, 10076-21, 10081-01, 10089-01, 10101-01, 10093-01

Distribution pattern

Worldwide Distribution - US Nationwide in the states of OH, FL, NH, TX, Sweden, Canada