Feb

2013

Class l HAMILTON-T1 Ventilator

Company:Hamilton Medical Inc.
Date of Enforcement Report 2/6/2013
Class l:

PRODUCT

HAMILTON-T1 Ventilator with software versions 1.1.2 or lower. The HAMILTON T-1 Ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics. Recall Number Z-0741-2013

REASON
Analysis of a customer complaint has shown that during ventilation of small pediatric patients with high airway resistance and low lung compliance, the oxygen consumption of a Hamilton T1 ventilator with software versions 1.1.2 and lower must be calculated using a larger margin than originally expected.

RECALLING FIRM/MANUFACTURER
Hamilton Medical Inc., Reno NV on 1/11/2013. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
97 total ventilators; 69 of part number 161005 and 28 of part number 161006

DISTRIBUTION
Nationwide and country of Switzerland

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About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Class l HAMILTON-T1 Ventilator

Amy Sellers

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