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U.S. Department of Health and Human Services

Class 1 Device Recall HAMILTON C2 Ventilator

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  Class 1 Device Recall HAMILTON C2 Ventilator see related information
Date Initiated by Firm June 15, 2023
Date Posted July 21, 2023
Recall Status1 Open3, Classified
Recall Number Z-2141-2023
Recall Event ID 92482
510(K)Number K121225  
Product Classification Ventilator, continuous, facility use - Product Code CBK
Product HAMILTON C2 Ventilator

Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates
Code Information Model: HAMILTON-C2 REF: 160001 UDI-DI Code: 07630002800372 Serial Numbers: 1549 1552 1554 1555 1557 1563 1565 1569 1796 1796 1797 1798 1800 1804 1806 1808 1809 1810 1811 1815 3001 3002 3004 3005 3036 3037 3038 3039 3040 3041 3042 3043 3053 3059 3067 3068 3070 3074 3075 3078 3081 3082 3085 3086 3087 3088 3098 3101 3106 3107 3115 3189 3191 3196 3204 3206 3207 3208 3209 3210 3211 3222 3223 3224 3225 3226 3227 3228 3229 3230 3231 3232 3233 3234 3235 3236 3237 3238 3239 3240 3241 3242 3243 3244 3245 3246 3247 3248 3249 3250 3251 3252 3253 3253 3254 3255 3256 3256 3257 3258 3259 3260 3261 3262 3263 3264 3265 3265 3267 3276 3278 3279 3280 3283 3283 3284 3287 3294 3297 3299 3302 3303 3304 3654 3785 3792 3792 3794 3796 3810 3811 3812 3812 3814 3816 3816 3818 3819 3820 3821 3821 3823 3824 3893 3929 4157 4158 4163 4165 4166 4168 4169 4171 4172 4174 4175 4178 4179 4181 4191 4193 4194 4195 4208 5168 5169 5170 5171 5172 5173 5174 5175 5176 5190 5193 5470 5647 5687 5700 5710 5711 5716 5722 5723 5746 5751 5754 5755 5766 5767 5768 5769 6022 6023 6024 6025 6534 6837 6877 6893 6904 7057 7165 7195 7716 7947 7948 7996 8600 8626 8627 8628 8629 8631 8632 8637 8641 8642 8810 8811 8812 8813 8814 8815 8816 8817 8818 9017 9018 9019 9220 9221 9237 10245 10732 10737 10737 10741 10744 10765 10770 10773 10775 10776 10778 10780 10808 11250 11300 12581 Puerto Rico Serial Numbers: 2848 2895 2900 3922 3924 3925 3936 3943 3944 3949 3952 3954 3955 3962 3964 3970 3984 3986 3989 4038 4039 4040 4041 4042 4043 4049 4052 5352 5973 5969 5975 5484 5945 5947 5971 5970 6502 6504 6501 6498 6499 6511 6950 7624 7694 7736 1549 1565 1804 1806 3001 3004 3005 3039 3041 3078 3081 3098 3189 3191 3206 3207 3208 3209 3211 3222 3223 3224 3225 3226 3228 3230 3231 3233 3234 3235 3237 3238 3239 3240 3241 3242 3243 3244 3245 3248 3250 3251 3253 3254 3258 3259 3265 4194 4208 8140 8143 8149 7724 8381 8382 8664 10172 10174 8668 8678 10097 10098 10099 10096 10104 10092 10090 10103 10174 10172 10180 10183 10085 10119 10080 10081 10082 10083 10089 10093 10095 10102 10112 10116 10118 10120 10122 10123 10129 10133 10134 10774 10742 10162 10759 10761 10766 10757 10758 11848 11877 11878 12576 12579 12703 12710 12708
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 399 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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