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U.S. Department of Health and Human Services

Class 1 Device Recall HamiltonT1 Ventilator

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  Class 1 Device Recall HamiltonT1 Ventilator see related information
Date Initiated by Firm July 26, 2023
Date Posted September 20, 2023
Recall Status1 Open3, Classified
Recall Number Z-2526-2023
Recall Event ID 92873
510(K)Number K181216  
Product Classification Ventilator, continuous, facility use - Product Code CBK
Product Hamilton-T1, REF: 161006, Intensive Care and Transport Ventilator
Code Information UDI: 07630002801850 & 07630002813532 / Affected Serial Numbers: 15929 17600 17661 17677 17698 17699 17741 17850 17877 17913 17925 17955 17957 17969 17975 17976 17982 17985 17986 17991 17993 17995 18009 18166 18183 18189 18191 18199 18224 18244 18251 18255 18256 18260 18263 18272 18273 18276 18288 18289 18305 18308 18333 18340 18349 18360 18363 18377 18378 18383 18414 18415 18419 18441 18451 18458 18461 18502 18537 18544 18550 18778 18784 19237 19290 19291 19292 19293 19294 19298 19304 19305 19470 19483 19490 26117
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 76 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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