22
Apr
2011

Cl ll Hamilton-G5 Ventilator

0

Company: Hamilton Medical Inc
Date of Enforcement Report 4/20/2011
Class ll:

PRODUCT
Hamilton-G5 Ventilator with software version V2.00x and Neonatal Option or V2.01x and Neonatal software. Hamilton-G5: catalog number 159001; Neonatal Software catalog number: 159700; Neonatal Option catalog number: 159187. Hamilton Medical Intended for use in the hospital and institutional environment where healthcare professionals provide patient care. Recall # Z-1928-2011

REASON
The adaptive volume/pressure regulation can be automatically and permanently reduced to PEEP + 3 mbar when a closed suctioning maneuver is performed on the patient and may be undetected by the operator..

RECALLING FIRM/MANUFACTURER
Recalling Firm: Hamilton Medical Inc., Reno, NV, by letter on February 16, 2011.
Manufacturer: Hamilton Medical AG, Bonaduz, Switzerland. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
97 units

DISTRIBUTION
MA, FL, GA, NC, MI, MO, TX, WV

About the author

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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