FDA Device recall Z-2142-2023

HAMILTON C3 Ventilator REF 160005 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally inf…

FDA Device
Class I
ongoing
Published 2023-08-02

On 2023-08-02 the FDA classified a Class I recall of HAMILTON C3 Ventilator REF 160005 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally inf… 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-2142-2023
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 C3 Ventilator REF 160005 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-C3 REF 160005 UDI-DI Code: 07630002801881 Serial Numbers: 1001 1003 1004 1006 1008 1009 1010 1011 1012… Model: HAMILTON-C3 REF 160005 UDI-DI Code: 07630002801881 Serial Numbers: 1001 1003 1004 1006 1008 1009 1010 1011 1012 1014 1019 1028 1030 1032 1042 1123 1174 1187 1192 1198 1201 1202 1206 1207 1219 1220 1221 1224 1225 1229 1232 1233 1259 1261 1264 1266 1458 1459 1461 1464 1465 1509 1510 1511 1512 1513 1514 1515 1516 1517 1528 1529 1530 1531 1534 1536 1584 1592 1597 1598 1623 1648 2004 2006 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2027 2040 2042 2044 2045 2046 2055 2064 2101 2112 2118 2119 2133 2139 2140 2171 2172 2173 2174 2175 2177 2253 2256 2257 2259 2260 2261 2262 2263 2265 2266 2285 2345 2346 2347 2360 2363 2364 2365 2367 2368 2416 2433 2481 2483 2483 2497 2499 2499 2550 2725 2733 2757 2953 3102 3104 3109 3110 3111 3112 3382 3385 3732 3786 3803 3930 4036 4037 4038 4042 4044 4057 4060 4068 4069 4070 4072 4075 4092 4092 4136 4137 4138 5307 5330 5353 5448 5509 5613 5775 5778 5781 5783 5785 5787 5788 5793 5794 5803 5812 5825 5833 5840 5845 5

code_info

Model: HAMILTON-C3 REF 160005 UDI-DI Code: 07630002801881 Serial Numbers: 1001 1003 1004 1006 1008 1009 1010 1011 1012…

Model: HAMILTON-C3 REF 160005 UDI-DI Code: 07630002801881 Serial Numbers: 1001 1003 1004 1006 1008 1009 1010 1011 1012 1014 1019 1028 1030 1032 1042 1123 1174 1187 1192 1198 1201 1202 1206 1207 1219 1220 1221 1224 1225 1229 1232 1233 1259 1261 1264 1266 1458 1459 1461 1464 1465 1509 1510 1511 1512 1513 1514 1515 1516 1517 1528 1529 1530 1531 1534 1536 1584 1592 1597 1598 1623 1648 2004 2006 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2027 2040 2042 2044 2045 2046 2055 2064 2101 2112 2118 2119 2133 2139 2140 2171 2172 2173 2174 2175 2177 2253 2256 2257 2259 2260 2261 2262 2263 2265 2266 2285 2345 2346 2347 2360 2363 2364 2365 2367 2368 2416 2433 2481 2483 2483 2497 2499 2499 2550 2725 2733 2757 2953 3102 3104 3109 3110 3111 3112 3382 3385 3732 3786 3803 3930 4036 4037 4038 4042 4044 4057 4060 4068 4069 4070 4072 4075 4092 4092 4136 4137 4138 5307 5330 5353 5448 5509 5613 5775 5778 5781 5783 5785 5787 5788 5793 5794 5803 5812 5825 5833 5840 5845 5

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-2142-2023%22

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