FDA Device recall Z-2140-2023

HAMILTON T1 Ventilator REF 161006 1610060 161009 1610090 Is intended to provide positive pressure ventilatory support to adults and pediatr…

FDA Device
Class I
ongoing
Published 2023-08-02

On 2023-08-02 the FDA classified a Class I recall of HAMILTON T1 Ventilator REF 161006 1610060 161009 1610090 Is intended to provide positive pressure ventilatory support to adults and pediatr… 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-2140-2023
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 T1 Ventilator REF 161006 1610060 161009 1610090 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-T1 REF: 161006 1610060 161009 1610090 UDI-DI Code: 07630002801850 07630002813532 07630002806091 076300… 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 4

code_info

Model: HAMILTON-T1 REF: 161006 1610060 161009 1610090 UDI-DI Code: 07630002801850 07630002813532 07630002806091 076300…

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 4

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-2140-2023%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.