Hamilton Medical, Inc.: HAMILTON C1 Ventilator REF 161001 1610010 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: 689 systems Lot/code info: 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 14426 14471 14678 14679 14681 14682 14683 14685 14686 14688 14693 14695 14698 14699 14701 14759 14769 14773 14813 15203 15354 15462 15487 15513 15565 15567 15568 15571 15576 15597 15604 15605 15613 15617 15622 15624 15636 15647 15657 15658 15659 15663 15675 15677 15681 15683 15689 15691 15694 15695 15697 15699 15717 15932 15970 16060 16101 16164 16182 16226 16236 16392 16397 16613 16970 17084 17149 17194 17201 17202 17204 17207 17208 17211 17213 17214 17221 17222 17223 17225 17226 17229 17236 172

UPC codes

07630002800747

Source

Official record: FDA (Device enforcement) ↗

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