Recall Z-1372-2018 ยท CBK Ventilator, Continuous, Facility Use
Hamilton Medical AG
Hamilton-C3 Ventilator Unit Intended to provide ventilator support to adults and pediatrics and optionally infants and neonates in the hospital.
| Date | Mar 12, 2018 |
| Status | Open, Classified |
| Reason | After two and a half years, the battery fuel gauge may indicate a higher battery charge than what is available. |
| Root cause | 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 | 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, Belg |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K161450 | HAMILTON-C3 Hamilton Medical AG, Apr 27, 2017 |