Z-1371-2018 Class II Ongoing

Recalled by Hamilton Medical AG — Bonaduz

Recall Details

Product Type
Devices
Report Date
April 18, 2018
Initiation Date
March 12, 2018
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
739 units total

Product Description

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

Reason for Recall

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

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.

Code Information

Product No. 160001 All Serial Numbers.