Recall Z-1624-2016 ยท CBK Ventilator, Continuous, Facility Use
Hamilton Medical, Inc.
Hamilton G5 with software version between v2.41, v2.42, v2.50. Catalog number: 1590001 and 1590002. Anesthesiology: Hamilton G5 ventilator is designed for intensive care ventilation of adult and pediatric patients, and optionally infants and neonatal patients. The device is intended for use in the hospital and institutional environment where health care professionals provide patient care.
| Date | May 9, 2016 (initiated Mar 9, 2016) |
| Status | Terminated |
| Reason | After performing the suctioning maneuver, including disconnecting the patient, suctioning , and reconnecting the patient, the preset pattern of ventilation many not continue as expected. |
| Root cause | Software design |
| Action | Hamilton Medical Inc. sent an" Medical Device Field Safety Corrective Action" letter dated March 7, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Hamilton Medical then had to compile a list of to whom they had distributed the affected ventilators and sent letters on April 6, 2016. Letters included the Medical Device Field Safety Corrective Action from Hamilton AG. Letters included immediate actions to be take by use and that reps will be visiting each site to upgrade ventilators to v 2.60 to alleviate the i |
| Quantity | 1115 |
| Distribution | US distribution only. |
| FDA record | Open on fda.gov |