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Recall Observatory FDA recall evidence

Device product

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

September 26, 2016

Class II

Product summary

Firm
Hamilton Medical, Inc.
Event
Event 75336
Status
Terminated
Classification
Class II
Quantity
44 units
Official record key
device-enforcement:Z-0666-2017

Official wording

Reason: 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

Derived failure modes

  • 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.