Open, Classified

Hamilton-C2 Ventilator Unit Intended to provide ventilator support to adults and pediatrics and optionally infants and neonates in the hospital.

FDA Recall Z-1371-2018 · Posted None

Recalling FirmHamilton Medical AG

Recall StatusOpen, Classified

Product CodeCBK

Date Initiated2018-03-12

Product Quantity739 units total

Reason for Recall

After two and a half years, the battery fuel gauge may indicate a higher battery charge than what is available.

Firm 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.

Root Cause

Other

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K121225HAMILTON-C2Hamilton Medical AG · 2012-11-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.