FDA Recall Terminated

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.

Recall: Z-1624-2016 · Initiated March 9, 2016

Recall

Recall Number: Z-1624-2016
Event Number: 73816
Firm: Hamilton Medical, Inc.
FEI Number: 2937708
Product Code: CBK
Status: Terminated
Root Cause: Software design
Initiated: March 9, 2016
Posted: May 9, 2016
Terminated: June 29, 2017
Address: 4990 Energy Way, Reno, NV, 89502-4123

Description

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.

Action

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.

Distribution

US distribution only.

Quantity

1115