Aug

2015

Cl II Hamilton-G5 Ventilators

Company: Hamilton Medical.
Date of Enforcement Report 8/5/2015
Class lI:

PRODUCT

Hamilton-G5 Ventilators with software versions V2.40/2.41 Catalog numbers for G5: 159001 and 159002. Software: 159700.. Intensive care ventilation of adult and pediatric patients and optionally infant and neonatal patients. Recall Number Z-2057-2015

REASON
Customer reports that the ventilator display can freeze. Ventilation continues but the information is no longer displayed on the screen and the user can no longer operate the device.

RECALLING FIRM/MANUFACTURER
Hamilton Medical Inc., Reno NV 3/24/2015. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
248

DISTRIBUTION
Nationwide

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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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Cl II Hamilton-G5 Ventilators

Amy Sellers

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