FDA-Device2016-05-18Class II

Hamilton G5 with software version between v2.41, v2.42, v2.50. Catalog number: 1590001 and 1590002. Anesthesiology: Hamilton G5 ventilator is designed for intensive care ventilation of adult and pediatric patients, and optionally infants and neonatal patients. The device is intended for use in the hospital and institutional environment where health care professionals provide patient care.

Hamilton Medical, Inc.
Hazard

After performing the suctioning maneuver, including disconnecting the patient, suctioning , and reconnecting the patient, the preset pattern of ventilation many not continue as expected.

Sold states
US distribution only.
Affected count
1115
Manufactured in
4990 Energy Way, N/A, Reno, NV, United States
Products
Hamilton G5 with software version between v2.41, v2.42, v2.50. Catalog number: 1590001 and 1590002. Anesthesiology: Hamilton G5 ventilator is designed for intensive care ventilation of adult and pediatric patients, and optionally infants and neonatal patients. The device is intended for use in the hospital and institutional environment where health care professionals provide patient care.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1624-2016

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