Class 1 Device Recall HamiltonT1 Ventilator

• Date Initiated by Firm: July 26, 2023
• Date Posted: September 20, 2023
• Recall Status: Open, Classified
• Recall Number: Z-2527-2023
• Recall Event ID: 92873
• 510(K)Number: K181216
• Product Classification: Ventilator, continuous, facility use - Product Code CBK
• Product: Hamilton-T1, REF: 161009, Intensive Care and Transport Ventilator
• Code Information: UDI: 07630002806091 & 07630002813549 / Affected Serial Numbers: 500816 501879 502181 502200 502587 502588 502589 502591 502647 502649 502650 502651 502687 502688 502690 502691 502696 502698 502699 502702 502704 502706 502709 502710 502711 502712 502714 502715 502718 502722 502723 502724 502725 502726 502727 502728 502730 502731 502732 502733 502734 502735 502736 502737 502738 502739 502740 502741 502742 502744 502745 502746 502747 502749 502750 502753 502757 502760 502761 502763 502764 502765 502766 502767 502770 502771 502772 502775 502776 502781 502782 502784 502789 502791 502792 502794 502795 502797 502799 502801 502802 502803 502804 502805 502807 502808 502809 502811 502812 502814 502815 502816 502817 502818 502820 502821 502824 502832 502835 502842 502843 502844 502846 502847 502850 502851 502852 502853 502854 502855 502856 502858 502859 502860 502861 502862 502863 502864 502865 502867 502868 502869 502870 502872 502873 502875 502877 502879 502880 502881 502882 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• Recalling Firm/ Manufacturer: Hamilton Medical, Inc.; 4655 Aircenter Cir; Reno NV 89502-5948
• For Additional Information Contact: Hamilton Medical Technical Support; 800-426-6331
• Manufacturer Reason for Recall: Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control board causing a short circuit on the board and/or the capacitor to lose function and lead to interruption of ventilation.
• FDA Determined Cause: Nonconforming Material/Component
• Action: On July 26, 2023, Hamilton Medical issued Urgent Medical Device Correction via E-Mail. Hamilton Medical asked consignees to take the following actions 1. Check for affected devices in your facility. Get in contact with your local distribution partner and get the devices serviced with high priority. 2. Please sign the enclosed/attached sheet to confirm that, as an End- Customer, you have received and duly noted this Medical Device Correction.
• Quantity in Commerce: 1216 units
• Distribution: Distribution US nationwide, including Puerto Rico. OUS: Not provided
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = CBK and Original Applicant = Hamilton Medical AG