| Class 2 Device Recall Hamilton G5 with software version between v2.41, v2.42, v2.50. | |
Date Initiated by Firm | March 09, 2016 |
Date Posted | May 09, 2016 |
Recall Status1 |
Terminated 3 on June 29, 2017 |
Recall Number | Z-1624-2016 |
Recall Event ID |
73816 |
510(K)Number | K070513 K103803 K131774 |
Product Classification |
Ventilator, continuous, facility use - Product Code CBK
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Product | Hamilton G5 with software version between v2.41, v2.42, v2.50.
Catalog number: 1590001 and 1590002.
Anesthesiology: Hamilton G5 ventilator is designed for intensive care ventilation of adult and pediatric patients, and optionally infants and neonatal patients. The device is intended for use in the hospital and institutional environment where health care professionals provide patient care. |
Code Information |
Serial numbers: 1278 1639 1686 1689 1691 1692 1695 1697 1699 1864 1984 2412 2413 2414 2417 2465 2505 2506 2521 2522 2523 2524 2525 2526 2527 2530 2531 2532 2591 2592 2593 2594 2595 2776 2780 2876 2877 2878 2880 2881 2882 2883 2884 2885 2886 2890 2894 3365 3366 3368 3370 3377 3611 3881 3882 3884 3885 3886 3887 3888 3889 3890 3914 4041 4044 4047 4057 4073 4074 4075 4077 4079 4080 4081 4088 4090 4091 4092 4093 4094 4095 4096 4097 4098 4099 4100 4101 4103 4104 4106 4108 4109 4110 4111 4112 4113 4115 4117 4118 4141 4144 4144 4145 4146 4147 4148 4149 4150 4223 4224 4226 4227 4345 4348 4351 4353 4354 4356 4357 4358 4359 4360 4365 4366 4598 4607 4625 4666 4671 4774 4779 4780 4781 4782 4783 4794 4904 4939 4946 4952 4956 5025 5026 5027 5028 5029 5030 5032 5038 5039 5040 5044 5045 5046 5047 5048 5050 5051 5052 5053 5054 5056 5057 5058 5061 5063 5064 5065 5080 5217 5248 5251 5252 5254 5256 5312 5357 5361 5362 5363 5374 5390 5395 5397 5437 5452 5457 5462 5465 5466 5468 5481 5523 5764 5774 5791 5794 5803 5815 5816 5818 5820 5825 5826 5827 5828 5829 5830 5831 5832 5834 5835 5836 5839 5842 5843 5888 5915 5930 5932 5933 5941 5948 6029 6031 6039 6062 6066 6072 6074 6075 6077 6078 6079 6080 6082 6083 6144 6211 6241 6247 6251 6261 6265 6276 6277 6278 6279 6291 6292 6293 6300 6303 6305 6306 6307 6309 6312 6315 6337 6377 6409 6411 6419 6422 6423 6432 6434 6438 6440 6441 6445 6451 6454 6470 6494 6495 6498 6499 6503 6504 6507 6508 6509 6511 6512 6515 6520 6556 6561 6614 6621 6625 6644 6647 6650 6653 6655 6656 6657 6658 6659 6661 6664 6669 6710 6740 6761 6763 6791 6795 6806 6832 6833 6835 6837 6838 6841 6856 6859 6890 6985 6986 6991 6992 6995 6999 7001 7021 7022 7030 7061 7077 7100 7329 7330 7336 7458 7526 7527 7528 7529 7530 7531 7532 7533 7534 7535 7536 7537 7538 7539 7558 7560 7566 7570 7585 7596 7597 7599 7605 7606 7646 7657 7658 7679 7684 7685 7919 7948 7984 8376 8390 8511 8512 8513 8535 8589 8610 8611 8617 8635 8637 8639 8643 8781 8783 8784 8785 8786 8791 8802 8803 8810 8816 8821 8822 8862 8866 8867 8868 8876 8877 8879 8896 8901 8902 8923 8925 8940 8946 8951 8952 8955 8956 8958 8959 8973 8977 8991 9033 9037 9044 9047 9049 9050 9052 9053 9054 9055 9056 9058 9066 9068 9069 9091 9092 9093 9094 9095 9096 9097 9098 9099 9100 9123 9124 9125 9126 9127 9128 9129 9130 9131 9132 9133 9134 9135 9136 9137 9138 9139 9140 9146 9147 9148 9149 9231 9232 9233 9234 9235 9236 9237 9238 9239 9240 9246 9247 9248 9249 9250 9251 9252 9253 9261 9262 9263 9264 9265 9266 9267 9268 9269 9270 9271 9272 9273 9274 9311 9312 9313 9314 9340 9341 9342 9343 9344 9345 9346 9347 9348 9349 9350 9351 9352 9353 9354 9355 9356 9357 9358 9359 9360 9361 9362 9363 9364 9365 9366 9367 9368 9369 9370 9371 9372 9373 9374 9375 9376 9377 9378 9379 9380 9382 9383 9384 9395 9396 9397 9398 9399 9400 9421 9422 9423 9424 9425 9426 9427 9428 9429 9430 9491 9492 9493 9494 9495 9496 9497 9498 9499 9500 9501 9502 9503 9504 9505 9506 9507 9510 9511 9512 9513 9514 9515 9516 9517 9518 9519 9520 9571 9592 9593 9594 9659 9660 9726 9727 9728 9729 9730 9737 9738 9739 9740 9741 9742 9743 9744 9745 9746 9747 9748 9749 9750 9751 9782 9783 9784 9785 9786 9787 9788 9789 9790 9791 9792 9793 9794 9795 9823 9824 9825 9826 9827 9828 9829 9830 9831 9832 9833 9846 9853 9856 9857 9858 9859 9860 9861 9863 9866 9884 9890 9892 9893 9894 9895 9896 9897 9898 9899 9901 9902
9903 9904 9905 9906 9907 9910 9917 9919 9922 9923 9924 9929 9930 9931 9953 9954 9955 9956 9957 9958 9959 9960 9961 9970 9971 9975 9977 9980 9983 9984 9986 9989 9991 9996 9998 10001 10012 10018 10019 10020 10021 10023 10027 10028 10029 10030 10031 10032 10033 10034 10035 10036 10037 10038 10039 10040 10041 10042 10043 10044 10045 10047 10049 10052 10053 10054 10055 10056 10057 10058 10059 10060 10061 10062 10063 10064 10065 10066 10067 10068 10069 10070 10071 10092 10093 10094 10095 10098 10100 10104 10105 10106 10107 10108 10109 10110 10111 10113 10114 10115 10128 10129 10130 10131 10142 10144 10147 10149 10151 10152 10154 10155 10157 10158 10159 10160 10162 10163 10168 10169 10170 10171 10172 10173 10174 10175 10176 10177 10188 10189 10190 10191 10192 10194 10196 10197 10198 10200 10201 10202 10204 10205 10206 10207 10208 10223 10224 10225 10233 10234 10264 10269 10292 10293 10364 10365 10372 10376 10379 10380 10393 10405 10411 10422 10423 10424 10426 10432 10441 10445 10447 10450 10462 10463 10464 10465 10466 10467 10468 10469 10470 10471 10472 10473 10475 10476 10477 10478 10479 10480 10481 10482 10483 10485 10486 10491 10498 10499 10500 10501 10511 10513 10515 10516 10518 10519 10520 10521 10522 10523 10524 10525 10526 10527 10530 10531 10532 10535 10545 10547 10548 10550 10551 10552 10553 10554 10555 10556 10557 10558 10559 10561 10562 10563 10571 10574 10576 10577 10578 10579 10580 10581 10582 10583 10584 10585 10586 10587 10588 10589 10590 10591 10592 10595 10598 10599 10600 10601 10613 10616 10617 10618 10619 10620 10621 10623 10624 10625 10626 10629 10630 10635 10638 10651 10657 10667 10674 10676 10677 10678 10681 10682 10684 10685 10689 10690 10692 10693 10694 10695 10696 10698 10700 10701 10717 10718 10721 10723 10724 10726 10727 10728 10729 10731 10733 10734 10735 10736 10737 10741 10757 10758 10761 10766 10776 10777 10784 10787 10790 10791 10792 10793 10794 10796 10826 10832 10833 10834 10835 10837 10838 10839 10840 10841 10842 10843 10844 10845 10846 10847 10848 10849 10850 10851 10852 10853 10854 10855 10856 10857 10860 10861 10862 10863 10864 10865 10866 10867 10868 10869 10870 10871 10872 10873 10876 10877 10881 10893 10902 10907 10909 10910 10953 10955 10960 10961 10963 10964 10965 10966 10967 10968 10970 10978 10979 10984 10986 10987 10988 10989 10990 10991 10993 10994 11041 11052 11053 11055 11056 11057 11058 11059 11060 11072 11073 11074 11075 11076 11078 11081 11083 11084 11085 11086 11092 11093 11140 11310 11311 11312 11313 11314 11315 11316 11317 11318 11319 11320 11321 11322 11323 11324 11325 11326 11327 11328 11329 11330 11331 11332 11333 11334 11335 11336 11337 11338 11339 11340 11341 11342 11343 |
Recalling Firm/ Manufacturer |
Hamilton Medical, Inc. 4990 Energy Way Reno NV 89502-4123
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For Additional Information Contact | Dan Belanger 775-858-3200 |
Manufacturer Reason for Recall | After performing the suctioning maneuver, including disconnecting the patient, suctioning , and reconnecting the patient, the preset pattern of ventilation many not continue as expected. |
FDA Determined Cause 2 | Software design |
Action | Hamilton Medical Inc. sent an" Medical Device Field Safety Corrective Action" letter dated March 7, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Hamilton Medical then had to compile a list of to whom they had distributed the affected ventilators and sent letters on April 6, 2016. Letters included the Medical Device Field Safety Corrective Action from Hamilton AG. Letters included immediate actions to be take by use and that reps will be visiting each site to upgrade ventilators to v 2.60 to alleviate the issue.
Distributors will update software and will provide an updated Operator's manual as soon as it is available.
Questions may be directed to 800-426-6331, Ext, 215. |
Quantity in Commerce | 1115 |
Distribution | US distribution only. |
Total Product Life Cycle | TPLC Device Report |
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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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = CBK
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