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U.S. Department of Health and Human Services

Class 1 Device Recall HAMILTON C1 Ventilator

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  Class 1 Device Recall HAMILTON C1 Ventilator see related information
Date Initiated by Firm June 15, 2023
Date Posted July 21, 2023
Recall Status1 Open3, Classified
Recall Number Z-2139-2023
Recall Event ID 92482
510(K)Number K181216  
Product Classification Ventilator, continuous, facility use - Product Code CBK
Product HAMILTON C1 Ventilator REF
161001
1610010

Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates
Code Information 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 17237 17238 17239 17241 17251 17259 17272 17479 17480 17481 17483 17610 17678 17698 17707 17716 17721 17736 17742 17746 17749 17751 17753 17754 17759 17770 17776 17787 17788 17798 17801 17802 17809 17839 17844 17974 18003 18022 18029 18031 18042 18068 18072 18073 18074 18076 18077 18079 18083 18089 18090 18097 18098 18102 18103 18108 18193 18420 18479 18564 18641 18754 18759 18765 18768 18773 18784 18793 18796 18799 18801 18804 18806 18807 18810 18826 18828 18831 18832 18833 18835 18837 18840 18847 18868 18879 18882 18885 18886 18913 18986 19213 19215 19258 19265 19266 19271 19274 19282 19301 19311 19346 19365 19411 19418 19419 19427 19431 19436 19437 19450 19458 19470 19473 19474 19476 19477 19488 19527 19561 19641 19855 19948 19949 19950 19951 21443 21444 21445 21446 21892 22091 22142 22143 22144 22151 22322 22332 22333 22334 22340 22342 22391 22393 22648 22649 22764 22783 23193 23369 23628 23641 23643 23649 23664 23668 23688 23694 23743 23766 23776 24014 24177 24205 24234 24237 24616 24780 24793 24910 24950 25087 25125 25126 25142 25143 25171 25183 25187 25437 25449 25511 25516 25576 25612 25653 25678 25723 25834 25852 25862 25899 26051 26069 26071 26073 26075 26077 26085 26089 26090 26113 26137 26198 26275 26324 26350 26356 26363 26368 26373 26385 26389 26401 26407 26412 26433 26490 26491 26540 26558 26574 26581 26639 26641 26725 26731 26733 26751 26758 26786 26787 26796 26801 26803 26804 26814 26816 26901 26913 27010 27201 27247 27422 27464 27516 27523 27528 27529 27544 27571 27611 27612 27616 27618 27621 27623 27628 27634 27635 27760 27986 28038 28060 28062 28079 28250 28268 28295 28311 28352 28371 28387 28402 28440 28475 28551 28803 28878 28880 28996 29002 29007 29012 29013 29017 29057 29058 29731 29732 29733 29737 29738 29739 30591 30595 31745 31746 31829 31861 32064 32078 32148 32227 32234 32235 32236 32243 32251 32254 32257 32276 32289 32557 32781 32836 32837 32895 32983 33232 33500 33506 33507 33512 33538 33542 33543 33565 33572 33635 33637 33639 33649 33652 33677 34353 34369 34370 34371 34372 34373 34802 34803 34804 34841 34940 34955 34965 34967 34973 34974 34975 34977 34978 34979 34980 34981 34983 34984 35136 35140 35198 35202 35213 35357 35494 35707 35708 35843 35969 35970 35974 36234 36241 36243 36290 36296 36299 36387 36391 36908 36924 37005 37163 37209 37210 37486 37662 37719 37720 37722 37723 37724 37726 37727 37738 37740 37742 37743 37745 37746 37749 37750 37752 37754 37755 37757 37779 37895 38355 38359 38363 38611 38651 38751 38827 38830 38831 38832 38833 39083 39106 39108 39137 39138 39139 39140 Puerto Rico Serial Numbers: 9722 12629 17109 22796 22797 22798 22799 22800 22801 22802 22803 22804 25530 23260 27982 19896
Recalling Firm/
Manufacturer		 Hamilton Medical, Inc.
4655 Aircenter Cir
Reno NV 89502-5948
For Additional Information Contact Kyle Hofer
800-426-6331
Manufacturer 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.
FDA Determined
Cause 2		 Software design
Action On 06/15/2023, the firm sent via email an "URGENT Medical Device Correction" Letter to customers informing them that, affected HAMILTON-C2/C3/C1/T1 ventilators which are used for long-term ventilation in neonatal group will switch to the "Ambient State" if the ventilation time is exceeding 91 days. During the "Ambient State" the ventilator will alarm audibly and visually displayed on the screen and would result in no active ventilation being provided to patients. Instructions for Customers: Required user actions if failure occurs: In such a case, perform the following actions steps: 1. Provide alternative ventilation immediately. 2. You must switch off ventilator power to exit the Ambient State . 3. Once patient safety is ensured, it is required to have the ventilator serviced. (After passing the service software the device can be returned to use.) For further information see chapter Ambient State in the respective Operator s Manual: HAMILTON-C1/T1 SW version d2.2.X Section 7.6.2 (pg. 130) HAMILTON-C2 SW version d2.2.X section B.8 (pg. 330) HAMILTON-C3 SW version d2.0.X section 7.7.3 (pg. 123) Mandatory periodic, preventive action: To avoid this malfunction, perform the following: The device needs to be restarted regularly. Note: Switching into standby is not sufficient. It is recommend to perform the restart of the device during the regular exchange of the breathing circuits (usually every 28 days). Preventing the failure from occurring through a software update: For HAMILTON-C1/T1: Update the devices to SW version 3.0.0 or higher. -Until the malfunction is corrected as part of this Medical Device Correction, please continue to follow the instructions in this Medical Device Correction. -Clearly display this correction notice at your site. For Questions: Hamilton Medical AG Technical Support at Tel. +41 58 610 10 20 Email: techsupport@hamilton-medical.com Added 08/30/2023 - Firm notified customers in Puerto Rico on ****
Quantity in Commerce 689 systems
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 Texas Utah Vermont Virginia Washington West Virginia Wisconsin Wyoming Added 08/30/2023 - Puerto Rico O.U.S.: Bahamas, Japan and Mexico
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = CBK and Original Applicant = Hamilton Medical AG
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