FDA Provides Update on Hamilton Medical’s Recall of Its C6 Intensive Care Ventilators
The FDA has issued an update on Hamilton Medical’s June 27 recall of its Hamilton-C6 intensive care ventilators, deeming it a Class 1 recall because of the risk of serious injury and death.
The recall was prompted by the discovery of a hardware issue with the ventilator’s status indicator board following customer complaints. The status indicator board may become loose, allowing liquid to enter between the indicator board and the ventilator’s main board.
This issue can cause the ventilator to have a technical fault and revert to a safety ventilation mode or revert to an ambient state, which means the patient breathes ambient room air with no assistance or support from the machine.
The 497 affected products were distributed from Aug. 31, 2017 to May 20. There have been 128 complaints globally, but no reports of injuries or deaths related to this issue so far, the FDA said.