FDA Device recall Z-2141-2023

HAMILTON C2 Ventilator Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and ne…

FDA Device
Class I
ongoing
Published 2023-08-02

On 2023-08-02 the FDA classified a Class I recall of HAMILTON C2 Ventilator Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and ne… by Hamilton Medical, citing due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior notice.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2141-2023
Classification	Class I
Status	ongoing
Initiated	2023-06-15
Published	2023-08-02
Last updated	2026-09-13 11:56 UTC
Company	Hamilton Medical
Distribution	AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY

Product

HAMILTON C2 Ventilator Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates

Reason

Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior notice.

Identifiers

code_info	Model: HAMILTON-C2 REF: 160001 UDI-DI Code: 07630002800372 Serial Numbers: 1549 1552 1554 1555 1557 1563 1565 1569 1796… 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

code_info

Model: HAMILTON-C2 REF: 160001 UDI-DI Code: 07630002800372 Serial Numbers: 1549 1552 1554 1555 1557 1563 1565 1569 1796…

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2141-2023%22

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