Recall Z-1874-2019 ยท CBK Ventilator, Continuous, Facility Use
Hamilton Medical AG
HAMILTON-G5, with software versions less than or equal to 2.60 The HAMILTON-G5/S1 ventilators are designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients. The device is intended for use in the hospital and institutional environment where health care professionals provide patient care.
| Date | Jul 11, 2019 (initiated Mar 25, 2019) |
| Status | Terminated |
| Reason | New software version for affected ventilators reduces the probability of the ventilator entering an ambient state, in which the inspiratory channel and expiratory valves are opened, letting the patient breathe room air unassisted. When the ventilator enters the ambient state, alternative ventilation must be provided immediately. |
| Root cause | Software design |
| Action | On 03/25/19, the firm, Hamilton AG, issued Medical Device Field Safety Corrective Action notices to customers via certified mail with receipt response. Customers were advised that if ventilators entered the ambient state, they should provide alternate ventilation immediately. In addition, in order to exit the ambient state, you must turn off ventilator power. The firm has developed a new software version, which reduces the probability of the ventilator entering an ambient state due to the occurrence of an error which leads to the user message "panel connection lost". The firm will contact |
| Quantity | 4338 units |
| Distribution | Worldwide Distribution- US (Nationwide Distribution): MI, WI, OR, MO, TX, NV, PA, SC, HI, MN, ND, NC, AZ, FL, CA, MA, GA, NY, VA, WA, IN, CO, LA, IL, OH, TN, SD, OK, MI, AR, C, AK, WV, NJ, IA, NE, KS, MT, NH, AL, MD, KY, CT, and RI. And (International Distribution): AT, BE, BG, CH, CZ, DE, DK, EE, |
| FDA record | Open on fda.gov |