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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 75844

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

Open FDA event record

Event summary

Timeline bucket
December 01, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Philips Electronics North America 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

Ingenia MR-OR; 781437, 781438 The MR-OR option is intended for allowing transfer of a neurosurgical patient from OR suite to MR suite and back with tools and instructions for proper positioning and MR imaging of those patients. MR-OR option also facilitates execution of simple neurosurgical procedures in the near proximity of the MR scanner without a need to move the patient back to the OR suite

Z-0825-2017
Recall number
Z-0825-2017
Initiated
December 01, 2016
Classification
Class II
Status
Terminated
Quantity
9

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Possibility that a patient or user may be exposed to a very small level of touch current.

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

Possibility that a patient or user may be exposed to a very small level of touch current.

Code information

781437: 15001, 15002, 15003 781438: 30001, 30002, 30003, 30004, 30005, 30006

Distribution pattern

Worldwide Distribution -US including CA, NY and Internationally to United Kingdom, Australia, Norway, and Thailand