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U.S. Department of Health and Human Services

Class 2 Device Recall HAMILTONC2

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  Class 2 Device Recall HAMILTONC2 see related information
Date Initiated by Firm March 12, 2018
Create Date April 12, 2018
Recall Status1 Open3, Classified
Recall Number Z-1371-2018
Recall Event ID 78599
510(K)Number K121225  
Product Classification Ventilator, continuous, facility use - Product Code CBK
Product Hamilton-C2 Ventilator Unit

Intended to provide ventilator support to adults and pediatrics and optionally infants and neonates in the hospital.
Code Information Product No. 160001  All Serial Numbers.
Recalling Firm/
Manufacturer		 Hamilton Medical AG
via Crusch 8
Bonaduz Switzerland
For Additional Information Contact
800-4266331
Manufacturer Reason
for Recall		 After two and a half years, the battery fuel gauge may indicate a higher battery charge than what is available.
FDA Determined
Cause 2		 Other
Action Customers were notified via letter on about 03/12/2018. The letter identified the affected device and described the issue. Instructions for medical facilities are to inspect the batteries for the battery manufacturing date and replace any batteries that are found to be in use for two years or more. Instructions for determining the battery manufacturing date are included in the Medical Device Field Safety Corrective Action Update attached to the letter. Questions or concerns can be directed to Bret Everett at 817-909-0308 or Hamilton Technical Support at 1-800-426-6331.
Quantity in Commerce 739 units total
Distribution Worldwide Distribution -- USA, including the states of AZ, CA, CO, FL, GA, HI, IL, IN, KY, MA, MI, MN, MO, MT, NC, ND, NE, NV, OH, OK, PA, SC, SD, TN, TX, UT, VA, VT, and WA; and, the countries of Algeria, Angola, Argentina, Armenia, Australia, Austria, Austria, Azerbaijan, Bangladesh, Belarus, Belgian, Bolivia, Brazil, Bulgaria, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czechia, Denmark, Dominican. Rep., Ecuador, Egypt, El Salvador, Estland, Finland, France, Gabon, Germany, Greece, Guatemala, Holland, Honduras, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Latvia, Lebanon, Libya, Lithuania, Malaysia, Maldives, Mauritius, Macedonia, Mexico, Mongolia, Morocco, Myanmar, Nepal, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Rwanda, Saudi Arabia, Scotland, Serbia, Seychelles, Slovakia, Slovenia, South Africa, Spain, SRI Lanka, Sudan, Suriname, Sweden, Sweden, Switzerland, Syria, Taiwan, Tajikistan, Thailand, Trinidad & Tobago, Tunisia, Turkey, UAE, Uganda, UK , Ukraine, Uruguay, Venezuela, Vietnam, and Yemen.
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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