Recall Z-1624-2016— Hamilton Medical, Inc.
Class II · Terminated
Class II FDA medical device recall by Hamilton Medical, Inc., initiated 2016-03-09, terminated 2017-06-29. It names 3 FDA 510(k) clearances: K131774, K103803, K070513. Product: 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.. Reason: After performing the suctioning maneuver, including disconnecting the patient, suctioning , and reconnecting the patient, the preset pattern of ventilation many not continue as expected..
- Recalling firm
- Hamilton Medical, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-03-09
- Terminated
- 2017-06-29
- Firm location
- Reno, NV, United States
510(k) clearances named in this recall
3 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
After performing the suctioning maneuver, including disconnecting the patient, suctioning , and reconnecting the patient, the preset pattern of ventilation many not continue as expected.
Data sourced from openFDA. This site is unofficial and independent of the FDA.