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U.S. Department of Health and Human Services

Class 2 Device Recall HamiltonG5 Ventilator

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 Class 2 Recall
HamiltonG5 Ventilator
see related information
Date Posted March 07, 2012
Recall Status1 Terminated on October 23, 2013
Recall Number Z-1185-2012
Recall Event ID 61238
Premarket Notification
510(K) Number
K103803 
Product Classification Ventilator, Continuous, Facility Use - Product Code CBK
Product 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.
Code Information All Hamilton 5
Recalling Firm/
Manufacturer
Hamilton Medical Inc
4990 Energy Way
P O Box 30008
Reno, Nevada 89502-3008
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Dan Belanger
800-426-6331 Ext. 215
Manufacturer Reason
for Recall
Hamilton-G5 ventilators with software version V2.0x may experience an unintentional change of the displayed ventilation mode under certain conditions.
FDA Determined
Cause 2
DESIGN: Software Design
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.
Quantity in Commerce 456 devices in US.
Distribution (USA) Nationwide Distribution including the states of: CA, CO, FL, GA, MA, MI, MO, NC, NV, NY, PA, TN, TX, VA and WV.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = CBK and Original Applicant = HAMILTON MEDICAL AG
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