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U.S. Department of Health and Human Services

Class 1 Device Recall HamiltonC1 Ventilator

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  Class 1 Device Recall HamiltonC1 Ventilator see related information
Date Initiated by Firm July 26, 2023
Date Posted September 20, 2023
Recall Status1 Open3, Classified
Recall Number Z-2525-2023
Recall Event ID 92873
510(K)Number K181216  
Product Classification Ventilator, continuous, facility use - Product Code CBK
Product Hamilton-C1, REF: 161001, Portable Intensive Care Ventilator
Code Information UDI: 07630002800747 & 07630002813426 / Affected Serial Numbers: 24177 24196 24216 24217 24219 24247 24250 24324 24360 24370 24431 24460 24467 24480 24487 24511 24523 24552 24556 24557 24558 24561 24564 24565 24571 24572 24574 24578 24583 24587 24591 24595 24612 24616 24620 24622 24651 24662 24672 24691 24965 24991 25006 25010 25011 25014 25022 25096 25109 25111 25118 25141 25142 25151 25152 25158 25163 25169 25171 25178 25183 25184 25185 25187 25189 25231 25232 25370 25433 25437 25456 25511 25516 25534 25538 25559 25576 25578 25612 25628 25632 25636 25678 25690 25712 25716 25721 25745 25747 25750 25753 25756 25757 25758 25759 25760 25761 25762 25763 25764 25769 25771 25777 25782 25784 25794 25809 25817 25822 25823 25830 25832 25834 25835 25841 25851 25852 25853 25862 25888 25893 25907 25913 25919 25924 25938 26007 26011 26042 26052 26063 26064 26069 26071 26081 26087 26201 26363 26390 26502 26510 26516 26639 26640 26641 26652 26660 26725 26731 26732 26733 26803 26857 26859 26870 26893 26896 26944 26977 27201 27504 27571 29013 31746
Recalling Firm/
Manufacturer		 Hamilton Medical, Inc.
4655 Aircenter Cir
Reno NV 89502-5948
For Additional Information Contact Hamilton Medical Technical Support
800-426-6331
Manufacturer Reason
for Recall		 Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control board causing a short circuit on the board and/or the capacitor to lose function and lead to interruption of ventilation.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action On July 26, 2023, Hamilton Medical issued Urgent Medical Device Correction via E-Mail. Hamilton Medical asked consignees to take the following actions 1. Check for affected devices in your facility. Get in contact with your local distribution partner and get the devices serviced with high priority. 2. Please sign the enclosed/attached sheet to confirm that, as an End- Customer, you have received and duly noted this Medical Device Correction.
Quantity in Commerce 164 units
Distribution Distribution US nationwide, including Puerto Rico. OUS: Not provided
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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