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U.S. Department of Health and Human Services

Class 1 Device Recall The HAMILTON T1

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 Class 1 Recall
The HAMILTON T1
see related information
Date Posted January 31, 2013
Recall Status1 Open
Recall Number Z-0741-2013
Recall Event ID 64117
Premarket Notification
510(K) Number
K120670 
Product Classification Ventilator, Continuous, Facility Use - Product Code CBK
Product HAMILTON-T1 Ventilator with software versions 1.1.2 or lower. The HAMILTON T-1 Ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics
Code Information Software Versions 1.1.2 and below; Part numbers 161005, 161006.
Recalling Firm/
Manufacturer
Hamilton Medical Inc
4990 Energy Way
P O Box 30008
Reno, Nevada 89502-4123
For Additional Information Contact Robert Hamilton
775-858-3200 Ext. 210
Manufacturer Reason
for Recall
Analysis of a customer complaint has shown that during ventilation of small pediatric patients with high airway resistance and low lung compliance, the oxygen consumption of a Hamilton T1 ventilator with software versions 1.1.2 and lower must be calculated using a larger margin than originally expected.
FDA Determined
Cause 2
DESIGN: Software Design
Action Hamilton sent a Field Safety alert letter dated January 11, 2013 to all customers. The letter identified the affected product, explained the potential problem and a included Medical Device Safety Alert and Corrective Action document. Hamilton is working on a new software version for this issue. Customers are asked to update their operator manual with the update oxygen consumption formula page which provided revised information for calculating oxygen capacity. When the new software is available, Hamilton will provide loaner devices to each location while their unit is being upgraded. Questions should be addressed to Hamilton Medical at 800-426-6331 ext 215.
Quantity in Commerce 97 total ventilators; 69 of part number 161005 and 28 of part number 161006
Distribution US Nationwide Distribution including the country of Switzerland.
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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