Hamilton Medical, Inc.: HAMILTON T1 Ventilator REF 161006 1610060 161009 1610090 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neona

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: 2319 systems Lot/code info: 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 4639 4696 4724 4726 4729 4730 4731 4775 4794 4915 4920 4928 4965 4968 4982 4992 4993 4996 5000 5001 5002 5007 5011 5034 5052 5057 5062 5063 5069 5074 5075 5113 5116 5120 5169 5181 5234 5238 5239 5246 5260 5261 5264 5267 5268 5271 5275 5277 5287 5288 5292 5293 5294 5296 5297 5300 5301 5302 5303 5305 5308 5311 5312 5314 5315 5319 5320 5323 5324 5326 5327 5328 5331 5332 5334 5335 5337 5339 5340 5341 5343 5397 5421 5427 5428 5430 5431 5435 5438 5439 5447 5450 5454 5460 5474 5481 5483 5484 5485 5486 5487 5488 5489 54

UPC codes

07630002801850, 07630002813532, 07630002806091, 07630002813549

Source

Official record: FDA (Device enforcement) ↗

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