HAMILTON-G5 Ventilator with software versions between V2.00 and V2.31. Anesthesiology: The HAMILTON-G5 ventilator is designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients
FDA Recall Z-0151-2016 · Posted 2015-11-04
Recalling FirmHamilton Medical, Inc.
Recall StatusTerminated
Product CodeCBK
Date Initiated2014-04-22
Date Terminated2017-08-24
Product Quantity1128
Reason for Recall
Ventilation and alarms of a HAMILTON-G5 ventilator can be suppressed unintentionally after the activation of a suctioning maneuver by the operator; this situation can occur regardless of the selected patient group (neonatal, pediatric and adult).
Firm Action
Hamilton Medical issued a letter dated April 22, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were notified that their Hamilton Medical Account Manager would contact them to coordinate the deactivation of the Ventilation Suppression feature. Customers were asked to review the Medical Device Field Safety Corrective Action.
Customers with questions were instructed to call 800-426-6331, Ext 215.
Root Cause
Device Design
Distribution Pattern
Nationwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.