Exact FDA event identifier

Event 75336

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

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Event summary

Timeline bucket: September 26, 2016
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Hamilton Medical, 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

Hamilton-MR1 Ventilator: Catalog# 161010 The Hamilton MR1 Ventilator is intended to provide pressure ventilator support to adults and pediatrics, and optionally infants and neonates. Intended areas of use include: MRI Dept., Intensive, intermediate, emergency and long-term acute care as well as transfer of patients within a hospital.

Z-0666-2017

Recall number: Z-0666-2017
Initiated: September 26, 2016
Classification: Class II
Status: Terminated
Recalling firm: Hamilton Medical, Inc.
Quantity: 44 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Oxygen tubing and the oxygen connector of the Hamilton-MR1 could potentially become loose during the preparation for ventilation.

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

Oxygen tubing and the oxygen connector of the Hamilton-MR1 could potentially become loose during the preparation for ventilation.

Code information

Serial Numbers between 2001 and 2103

Distribution pattern

Nationwide Distribution