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U.S. Department of Health and Human Services

Class 2 Device Recall HamiltonC6

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 Class 2 Device Recall HamiltonC6see related information
Date Initiated by FirmSeptember 22, 2022
Date PostedNovember 18, 2022
Recall Status1 Open3, Classified
Recall NumberZ-0267-2023
Recall Event ID 90916
510(K)NumberK201658 
Product Classification Ventilator, continuous, facility use - Product Code CBK
ProductHamilton-C6
Code Information Model Number: 160021 UDI-DI Code: 07630002808590 All Serial Numbers U.S. Serial Numbers 6093 6159 6274 6276 6309 6320 6327 6464 6512 6545 6674 6789 7136 7173 7191 7273 7279 7422 7432 7569 7572 7587 7644 7676 7782 7783 7784 7786 7788 7789 7790 7792 7793 7794 7795 7796 7797 7798 7799 7801 7806 7807 7812 7813 7837 7901 7923 7969 8182 8343 8394 8395 8399 8420 8421 8422 8423 8424 8497 8519 8593 8661 8668 8670 8673 8675 8676 8678 8707 8709 8712 9028 9029 9032 9033 9042 9043 9044 9046 14784 4833 5663 5679 5681 5939 6075 6149 6157 6212 6219 6231 6280 6349 6350 6416 6480 6505 6516 6537 6562 6566 6579 6641 6658 6671 6723 6774 6790 6829 6858 6868 6871 6896 6907 6925 6932 6937 6944 6952 6953 6965 6995 7004 7033 7066 7113 7115 7117 7122 7130 7138 7150 7156 7165 7174 7177 7196 7201 7252 7265 7307 7349 7358 7382 7410 7420 7581 7586 7608 7614 7656 7666 7695 7719 7740 7754 7772 7777 7787 7802 7808 7809 7819 7821 7822 7826 7827 7831 7836 7845 7861 7884 7887 7888 7893 7894 7898 7938 7966 7980 7986 7993 7994 8003 8005 8049 8052 8063 8070 8082 8087 8097 8099 8102 8115 8121 8122 8148 8151 8178 8235 8249 8255 8256 8258 8261 8281 8297 8306 8310 8311 8313 8322 8325 8344 8346 8348 8356 8371 8401 8406 8409 8413 8477 8490 8517 8535 8568 8590 8594 8597 8599 8601 8603 8604 8616 8620 8658 8702 8706 8713 8714 8715 8717 8718 8719 8720 8722 8723 8725 8726 8727 8844 8845 8846 8847 8849 8850 8866 9036 9050 9051 9054 9062 9063 9064 9067 9069 9071 9073 9075 9076 9077 9080 9081 9091 9098 9099 9100 9101 9102 9103 9105 9106 9107 9108 9109 9110 9118 9120 9121 9124 9125 9126 9127 9128 9129 9130 9131 9132 9133 9134 9137 9138 9192 9224 9225 9227 9228 9229 9230 9231 9232 9233 9235 9236 9237 9239 9241 9242 9243 9244 9248 9257 9258 9259 9260 9290 9291 9292 9293 9294 9297 9298 9299 9300 9301 9303 9324 9325 9329 9337 9348 9352 9353 9354 9422 9423 9424 9425 9426 9427 9428 9429 9430 9432 9433 9452 9458 9459 9460 9462 9463 9464 9465 9466 9487 9488 9490 9491 9508 9527 9535 9543 9545 9553 9575 9576 9577 9578 9579 9582 9590
Recalling Firm/
Manufacturer		 Hamilton Medical AG
Parc Industrial Vial 10
Domat/Ems Switzerland
For Additional Information ContactKyle Hofer
800-426-6331
Manufacturer Reason
for Recall		Due to a malfunction related to the backlight on the ventilator screen. The screen goes black for approximately 2-3 seconds, but it brightens up again when the backlight switches on again.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 10/19/2022, Hamilton Medical, Inc. sent an "URGENT - Medical Device Correction" Letter via email to customers informing them the firm had received a complaint report associated with the backlight of the HAMILTON C-6 display failing. The failure is attributed to a reset of the HMI controller reset with causes the display to fail for 2-3 seconds. Hamilton Medical is notifying customer that this failure does not affect or interrupt the device's ventilation function. Customers are instructed to: -Sign the enclosed sheet confirming that they have received and understood this Medical Device Correction. Also, continue to notify their local distribution partner of any cases of the aforementioned malfunction. No further action on their part is required. -Keep this information sheet with your HAMILTON-C6 Operator's Manual and prominently displayed as a constant reminder to the device users. For questions, contact - Hamilton Medical AG Technical Support Parc Industrial Vial 10 CH-7013 Domat/Ems Switzerland Tel. +41 58 610 10 20 e-mail: techsupport@hamilton-medical.com
Quantity in Commerce8,229 total systems worldwide (U.S. 443 systems)
DistributionU.S. Nationwide distribution including in the states of CA, FL, GA, ID, IN, KS, KY, MA, MI, MO, NV, NM, NY, NC, OH, PA, Puerto Rico, SC, TX, VA, WA, WV, WI, and WY.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = CBK
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