Class 1 Device Recall The HAMILTON T1

• Date Initiated by Firm: December 19, 2012
• Date Posted: January 31, 2013
• Recall Status: Terminated on April 22, 2014
• Recall Number: Z-0741-2013
• Recall Event ID: 64117
• 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 NV 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: 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = CBK