Hamilton Medical, Inc.: HAMILTON C3 Ventilator REF 160005 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates

Hazard

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

Details from the source

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. 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 Texa Quantity: 701 systems Lot/code info: 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 5851 5853 5862 5876 5912 5918 5919 5920 5922 5926 5939 5940 5941 5942 5943 5944 5945 5946 5947 5977 5979 5980 5987 5988 5989 5990 5991 5992 5993 5994 5995 5996 5997 5998 5999 6000 6001 6011 6012 6013 6014 6015 6016 6017 6019 6021 6026 6027 6033 6034 6035 6036 6037 6038 6039 6041 6044 6055 6057 6823 6983 6991 7086 7100 7142 7175 7177 7178 7179 7180 7181 7182 7186 7187 7190 7192 7193 7194 7195 7196 7197 7198 7199 7204 7206 7208 7225 7234 7258 7283 7336 7539 7541 7543 7544 7545 7546 7554 7572 7573 7

UPC codes

07630002801881

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.