FDA recall Z-0267-2023

Product

Hamilton-C6

Reason for recall

Due to a malfunction related to the backlight on the ventilator screen. The screen goes black for approximately 2-3 seconds, but it brightens up again when the backlight switches on again.

Distribution

U.S. Nationwide distribution including in the states of CA, FL, GA, ID, IN, KS, KY, MA, MI, MO, NV, NM, NY, NC, OH, PA, Puerto Rico, SC, TX, VA, WA, WV, WI, and WY.

Key facts

Status

Ongoing

Initiation date

2022-09-22

Report date

2022-11-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Domat/Ems, N/A, Switzerland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0267-2023