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U.S. Department of Health and Human Services

Class 2 Device Recall Continuous Ventilator

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  Class 2 Device Recall Continuous Ventilator see related information
Date Initiated by Firm March 09, 2018
Create Date August 14, 2018
Recall Status1 Terminated 3 on March 18, 2019
Recall Number Z-2796-2018
Recall Event ID 80467
510(K)Number K161450  
Product Classification Ventilator, continuous, facility use - Product Code CBK
Product Hamilton-C3 Ventilator Unit

Product Usage:
The HAMILTON-C3 ventilator is intended to provide positive pressure ventilator support to adults, pediatrics, infants and neonates depending on its configuration. The device is used in the intensive care ward, intermediate care ward, emergency ward, long term acute care hospital or in the recovery room, and during transfer of ventilated patients within the hospital.
Code Information Serial Number: 3084, 3088
Recalling Firm/
Manufacturer		 Hamilton Medical AG
Via Crusch 8
Bonaduz Switzerland
For Additional Information Contact
800-4266331
Manufacturer Reason
for Recall		 An out of specification component on the control board may cause the ventilator to open the inspiratory channel and the expiratory valve. The ventilator will shut down and an emergency buzzer providing an acoustic alarm and the blinking alarm LED on the device s front side.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Hamilton Medical notified customers on about 03/09/2018 via letter. Instructions included that a Hamilton Medical Field Service Representative will be in contact with each customer to schedule the correction. Questions or concerns can be directed to Hamilton Technical Support at 1-800-426-6331, option #2.
Quantity in Commerce 2 devices
Distribution US distribution to CA, CO, IL, LA, MN, NY, OK, VA, WI. Worldwide distribution to China, Germany, India, Indonesia, Israel, Kazakhstan, Korea, Pakistan, Taiwan, Poland, Armenia.
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
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