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U.S. Department of Health and Human Services

Class 1 Device Recall HAMILTON T1 Ventilator

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  Class 1 Device Recall HAMILTON T1 Ventilator see related information
Date Initiated by Firm June 15, 2023
Date Posted July 21, 2023
Recall Status1 Open3, Classified
Recall Number Z-2140-2023
Recall Event ID 92482
510(K)Number K181216  
Product Classification Ventilator, continuous, facility use - Product Code CBK
Product HAMILTON T1 Ventilator REF
161006
1610060
161009
1610090

Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates
Code Information Model: HAMILTON-T1 REF: 161006 1610060 161009 1610090 UDI-DI Code: 07630002801850 07630002813532 07630002806091 07630002813549 Serial Numbers: 3057 3058 3063 3070 3077 3081 3085 3089 3093 3112 3115 3119 3121 3124 3126 3127 3129 3131 3132 3133 3136 3138 3140 3168 3169 3185 3191 3193 3195 3199 3200 3235 3236 3241 3243 3245 3247 3249 3250 3258 3259 3263 3275 3280 3299 3307 3309 3311 3312 3313 3317 3320 3340 3574 3576 3577 3579 3580 3604 3605 3613 3616 3618 3621 3629 3657 3658 3661 3663 3666 3668 3672 3691 3702 3703 3716 3731 3731 3739 3744 3746 3747 3748 3749 3750 3751 3761 3785 3792 3803 3824 3829 3832 3840 3848 3852 3853 3854 3862 3869 3875 3886 3889 3890 3902 3921 3933 3937 3953 3960 3961 3971 3973 3974 3983 3986 3987 3989 3990 4017 4046 4050 4050 4052 4052 4053 4057 4066 4070 4075 4076 4086 4090 4093 4094 4096 4100 4102 4118 4121 4123 4244 4339 4341 4349 4354 4355 4416 4422 4429 4502 4516 4518 4524 4527 4534 4535 4551 4552 4583 4584 4592 4593 4595 4596 4599 4600 4629 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Recalling Firm/
Manufacturer		 Hamilton Medical, Inc.
4655 Aircenter Cir
Reno NV 89502-5948
For Additional Information Contact Kyle Hofer
800-426-6331
Manufacturer Reason
for Recall		 Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior notice.
FDA Determined
Cause 2		 Software design
Action On 06/15/2023, the firm sent via email an "URGENT Medical Device Correction" Letter to customers informing them that, affected HAMILTON-C2/C3/C1/T1 ventilators which are used for long-term ventilation in neonatal group will switch to the "Ambient State" if the ventilation time is exceeding 91 days. During the "Ambient State" the ventilator will alarm audibly and visually displayed on the screen and would result in no active ventilation being provided to patients. Instructions for Customers: Required user actions if failure occurs: In such a case, perform the following actions steps: 1. Provide alternative ventilation immediately. 2. You must switch off ventilator power to exit the Ambient State . 3. Once patient safety is ensured, it is required to have the ventilator serviced. (After passing the service software the device can be returned to use.) For further information see chapter Ambient State in the respective Operator s Manual: HAMILTON-C1/T1 SW version d2.2.X Section 7.6.2 (pg. 130) HAMILTON-C2 SW version d2.2.X section B.8 (pg. 330) HAMILTON-C3 SW version d2.0.X section 7.7.3 (pg. 123) Mandatory periodic, preventive action: To avoid this malfunction, perform the following: The device needs to be restarted regularly. Note: Switching into standby is not sufficient. It is recommend to perform the restart of the device during the regular exchange of the breathing circuits (usually every 28 days). Preventing the failure from occurring through a software update: For HAMILTON-C1/T1: Update the devices to SW version 3.0.0 or higher. -Until the malfunction is corrected as part of this Medical Device Correction, please continue to follow the instructions in this Medical Device Correction. -Clearly display this correction notice at your site. For Questions: Hamilton Medical AG Technical Support at Tel. +41 58 610 10 20 Email: techsupport@hamilton-medical.com Added 08/30/2023 - Firm notified customers in Puerto Rico on ****
Quantity in Commerce 2319 systems
Distribution U.S.: Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin Wyoming Added 08/30/2023 - Puerto Rico O.U.S.: Bahamas, Japan and Mexico
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
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