According to the FDA, a Class I recall has been issued for Hamilton Medical’s Hamilton-G5 ventilator due to due to the potential for the ventilator to stop working and enter an ambient state.
FDA recall info:
- Hamilton Medical AG Hamilton-G5 Ventilator (PN 159001)
- Serial Numbers: All serial numbers below 16192 with software versions ? 2.60
- Manufacturing Dates: November 29, 2007 – October 31, 2018
- Distribution Dates: November 29, 2007 – October 31, 2018
- Devices Recalled in the U.S.: 4338 Units
- Date Initiated by Firm: February 11, 2019
According to the FDA, Hamilton Medical AG is recalling Hamilton-G5 Ventilators due to the potential for “Panel connection lost” error message resulting in the ventilator to stop working and enter an ambient state.
When the ventilator enters an ambient state, the patient breathes room air unassisted and the ventilator sounds a high priority alarm with visual blinking LEDs alerting medical staff, the FDA said in a media advisory. When the ventilator enters the ambient state, alternative ventilation must be provided immediately.
The FDA reports that Hamilton Medical AG has received 14 complaints associated with the error message, however no patient injury or death have been reported due to the issue.
More information is available on the FDA’s website.