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 Status: Terminated 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
• 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 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• Recalling Firm/ Manufacturer: Hamilton Medical, Inc.; 4990 Energy Way; Reno NV 89502-4123
• 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: 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

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.

• 510(K) Database: 510(K)s with Product Code = CBK and Original Applicant = HAMILTON MEDICAL AG