FDA Device recall Z-2139-2023

HAMILTON C1 Ventilator REF 161001 1610010 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and option…

FDA Device
Class I
ongoing
Published 2023-08-02

On 2023-08-02 the FDA classified a Class I recall of HAMILTON C1 Ventilator REF 161001 1610010 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and option… 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-2139-2023
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 C1 Ventilator REF 161001 1610010 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-C1 REF: 161001 1610010 UDI-DI Code: 07630002800747 Serial Numbers: 6006 6023 6024 6203 6264 6267 6318… Model: HAMILTON-C1 REF: 161001 1610010 UDI-DI Code: 07630002800747 Serial Numbers: 6006 6023 6024 6203 6264 6267 6318 6323 6586 7075 7078 7087 7283 7867 7869 7870 7874 7878 7887 7902 7923 7932 7935 8259 8277 8431 8444 8463 8749 8940 8943 8951 9216 9228 9334 9392 9405 9409 9463 9467 9508 9571 9577 9584 9591 9597 9622 9629 9634 9652 9653 9654 9656 9664 9685 9704 9726 9728 9742 9742 9988 9995 10187 10194 10236 10241 10259 10262 10273 10361 10365 10371 10376 10383 10843 11016 11425 11493 11495 11499 11504 11530 11533 11574 11576 11577 11578 11579 11656 11751 11976 11992 12002 12024 12029 12091 12297 12312 12319 12319 12338 12339 12340 12343 12344 12345 12347 12353 12354 12355 12360 12361 12362 12363 12364 12365 12371 12373 12374 12375 12377 12382 12383 12388 12390 12397 12408 12410 12412 12413 12414 12417 12419 12426 12429 12431 12432 12439 12439 12441 12467 12998 13010 13018 13025 13349 13375 13425 13427 13440 14267 14307 14307 14309 14323 14324 14325 14330 14331 14336 14338 14345 14360

code_info

Model: HAMILTON-C1 REF: 161001 1610010 UDI-DI Code: 07630002800747 Serial Numbers: 6006 6023 6024 6203 6264 6267 6318…

Model: HAMILTON-C1 REF: 161001 1610010 UDI-DI Code: 07630002800747 Serial Numbers: 6006 6023 6024 6203 6264 6267 6318 6323 6586 7075 7078 7087 7283 7867 7869 7870 7874 7878 7887 7902 7923 7932 7935 8259 8277 8431 8444 8463 8749 8940 8943 8951 9216 9228 9334 9392 9405 9409 9463 9467 9508 9571 9577 9584 9591 9597 9622 9629 9634 9652 9653 9654 9656 9664 9685 9704 9726 9728 9742 9742 9988 9995 10187 10194 10236 10241 10259 10262 10273 10361 10365 10371 10376 10383 10843 11016 11425 11493 11495 11499 11504 11530 11533 11574 11576 11577 11578 11579 11656 11751 11976 11992 12002 12024 12029 12091 12297 12312 12319 12319 12338 12339 12340 12343 12344 12345 12347 12353 12354 12355 12360 12361 12362 12363 12364 12365 12371 12373 12374 12375 12377 12382 12383 12388 12390 12397 12408 12410 12412 12413 12414 12417 12419 12426 12429 12431 12432 12439 12439 12441 12467 12998 13010 13018 13025 13349 13375 13425 13427 13440 14267 14307 14307 14309 14323 14324 14325 14330 14331 14336 14338 14345 14360

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-2139-2023%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.