Class 1 Device Recall HAMILTON C3 Ventilator

• Date Initiated by Firm: June 15, 2023
• Date Posted: July 21, 2023
• Recall Status: Open, Classified
• Recall Number: Z-2142-2023
• Recall Event ID: 92482
• 510(K)Number: K201306
• Product Classification: Ventilator, continuous, facility use - Product Code CBK
• Product: HAMILTON C3 Ventilator REF 160005 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates
• Code Information: Model: HAMILTON-C3 REF 160005 UDI-DI Code: 07630002801881 Serial Numbers: 1001 1003 1004 1006 1008 1009 1010 1011 1012 1014 1019 1028 1030 1032 1042 1123 1174 1187 1192 1198 1201 1202 1206 1207 1219 1220 1221 1224 1225 1229 1232 1233 1259 1261 1264 1266 1458 1459 1461 1464 1465 1509 1510 1511 1512 1513 1514 1515 1516 1517 1528 1529 1530 1531 1534 1536 1584 1592 1597 1598 1623 1648 2004 2006 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2027 2040 2042 2044 2045 2046 2055 2064 2101 2112 2118 2119 2133 2139 2140 2171 2172 2173 2174 2175 2177 2253 2256 2257 2259 2260 2261 2262 2263 2265 2266 2285 2345 2346 2347 2360 2363 2364 2365 2367 2368 2416 2433 2481 2483 2483 2497 2499 2499 2550 2725 2733 2757 2953 3102 3104 3109 3110 3111 3112 3382 3385 3732 3786 3803 3930 4036 4037 4038 4042 4044 4057 4060 4068 4069 4070 4072 4075 4092 4092 4136 4137 4138 5307 5330 5353 5448 5509 5613 5775 5778 5781 5783 5785 5787 5788 5793 5794 5803 5812 5825 5833 5840 5845 5851 5853 5862 5876 5912 5918 5919 5920 5922 5926 5939 5940 5941 5942 5943 5944 5945 5946 5947 5977 5979 5980 5987 5988 5989 5990 5991 5992 5993 5994 5995 5996 5997 5998 5999 6000 6001 6011 6012 6013 6014 6015 6016 6017 6019 6021 6026 6027 6033 6034 6035 6036 6037 6038 6039 6041 6044 6055 6057 6823 6983 6991 7086 7100 7142 7175 7177 7178 7179 7180 7181 7182 7186 7187 7190 7192 7193 7194 7195 7196 7197 7198 7199 7204 7206 7208 7225 7234 7258 7283 7336 7539 7541 7543 7544 7545 7546 7554 7572 7573 7597 7603 7768 7797 7814 8168 8275 8276 8277 8320 8324 8385 8506 8686 8691 8692 8693 8750 8776 8831 8838 9320 9324 9335 9337 9340 9345 9346 9350 9361 9364 9394 9565 9627 9628 9680 9711 9818 9819 9821 9823 9828 9844 9855 9858 9862 9905 10009 10012 10014 10015 10031 10108 10110 10112 10117 10130 10181 10212 10260 10290 10711 10723 10726 10750 10755 10790 10880 10972 10984 11002 11023 11027 11038 11041 11092 11093 11147 11389 11394 11397 11403 11412 11414 11421 11427 11428 11432 11436 11561 11571 11572 11575 11578 11625 11628 11638 11688 11689 11692 11694 11696 11707 11710 11712 11717 11718 11733 11735 11736 11738 11771 11780 11783 11784 11786 11926 12069 12070 12071 12184 12193 12195 12196 12199 12201 12324 12325 12333 12334 12339 12342 12343 12345 12353 12354 12356 12359 12360 12362 12365 12367 12368 12370 12372 12375 12379 12380 12382 12395 12420 12451 12456 12469 12470 12477 12484 12485 12486 12490 12491 12492 12494 12495 12508 12587 12613 12629 12933 13791 13828 14282 14284 14285 14286 14779 14784 14792 14816 14878 14900 14904 14924 14925 14926 14927 14928 14934 14987 14990 14995 14996 14999 15485 15486 15492 15497 15503 Puerto Rico Serial Numbers: 1086 1650 1655 2357 2357 2366 2366 2369 2369 2371 2371 2372 2373 2373 2374 2374 2375 2375 2491 2494 2509 2510 2511 2513 2515 2516 2517 2518 2519 2520 2521 2523 2524 2525 2526 2527 2528 2529 2530 2531 2532 2533 2534 2535 2536 2537 2538 2539 2560 2562 2564 2565 2566 2734 2875 2877 3861 4407 4513 4516 4564 4616 5343 5428 5631 5653 5655 5656 5793 5799 5800 5805 5808 5961 5962 5963 5964 5965 5966 5967 5968 6066 6067 6068 6069 6070 6588 6590 6594 6595 6604 6605 6606 6607 6608 6609 6613 6614 6617 6618 6621 6622 6629 6631 6633 6634 6635 6636 6637 6638 6640 6641 6644 6646 6647 6650 6651 6652 6653 6654 6655 6656 6657 6658 7222 7224 7226 7227 7228 7229 7230 7231 7232 7233 7242 7247 7249 7251 7252 7253 7255 7256 7257 7313 7604 7605 7606 7607 7608 7609 7611 7612 8110 8196 8221 8272 8273 8280 8286 8299 8304 8310 8314 8316 8328 8334 8346 8347 8351 9169 9174 9180 9182 9184 9188 9194 9196 9203 9204 9205 9206 9208 9216 9217 9220 9223 9227 9910 9931 9947 9953 9954 9982 11598 11601 11663 11671 11676 11682 11955 11960 11982 11986 11991 11995 11996 11998 12603 12604 12762 12763 12768 12771 12779 12780 12801 16212 16213
• 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: 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: 701 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