HAMILTON G5 ventilators with software version V2.0x. Hamilton Medical AG, Switzerland Imported and distributed by Hamilton Medical, 4990 Energy Way, Reno, NV 89502. Product Usage: Hamilton-G5 Ventilators are designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients. The devices are intended for use in the hospital and institutional environment with trained healthcare professionals.
FDA Recall Z-1185-2012 · Posted 2012-03-07
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Recalling FirmHamilton Medical Inc
Recall StatusTerminated
Product CodeCBK
Date Initiated2012-02-06
Date Terminated2013-10-23
Product Quantity456 devices in US.
Reason for Recall
Hamilton-G5 ventilators with software version V2.0x may experience an unintentional change of the displayed ventilation mode under certain conditions.
Firm Action
Hamilton Medical sent a Medical Device Safety Alert and Correction Action letter dated February 17, 2011 to all affected customers via a traceable method. The letter identified the affected product, problem and immediate actions required by operators, distributor and manufacturer. The letter states that a Hamilton Medical Account manager will contact customers to schedule a convenient time for the Technical Support Department to install the software update. Questions or concerns may be directed to Technical Support Manager at 800-426-6331, Ext 125.
Root Cause
Software design
Distribution Pattern
(USA) Nationwide Distribution including the states of: CA, CO, FL, GA, MA, MI, MO, NC, NV, NY, PA, TN, TX, VA and WV.
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.
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