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U.S. Department of Health and Human Services

Class 1 Device Recall HamiltonMR1 Ventilator

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 Class 1 Device Recall HamiltonMR1 Ventilatorsee related information
Date Initiated by FirmJuly 26, 2023
Date PostedSeptember 20, 2023
Recall Status1 Open3, Classified
Recall NumberZ-2528-2023
Recall Event ID 92873
510(K)NumberK153046 
Product Classification Ventilator, continuous, facility use - Product Code CBK
ProductHamilton-MR1, REF: 161010, Intensive Care Ventilator
Code Information UDI: 07630002800761 & 07630002813556 / Affected Serial Numbers: 3422 3423 3424 3425 3426 3427 3428 3429 3469 3503 3510 3800
Recalling Firm/
Manufacturer		 Hamilton Medical, Inc.
4655 Aircenter Cir
Reno NV 89502-5948
For Additional Information ContactHamilton 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
ActionOn 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 Commerce12 units
DistributionDistribution US nationwide, including Puerto Rico. OUS: Not provided
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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