Hamilton G5 with software version between v2.41, v2.42, v2.50. Catalog number: 1590001 and 1590002. Anesthesiology: Hami

FDA device recall Z-1624-2016 · posted 2016-05-09 · Terminated

Recall details

Recalling firm: Hamilton Medical, Inc.
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.
Action taken: Hamilton Medical Inc. sent an" Medical Device Field Safety Corrective Action" letter dated March 7, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Hamilton Medical then had to compile a list of to whom they had distributed the affected ventilators and sent letters on April 6, 2016. Letters included the Medical Device Field Safety Corrective Action from Hamilton AG. Letters included immediate actions to be take by use and that reps will be visiting each site to upgrade ventilators to v 2.60 to alleviate the issue. Distributors will update software and will provide an updated Operator's manual as soon as it is available. Questions may be directed to 800-426-6331, Ext, 215.
Root cause: Software design
Status: Terminated
Product code: CBK
Quantity affected: 1115
Distribution: US distribution only.
Date initiated: 2016-03-09
Date posted: 2016-05-09
Date terminated: 2017-06-29
Location: Reno, NV

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