Recall Z-0267-2023— Hamilton Medical AG

Name: FDA recall Z-0267-2023
Creator: U.S. Food and Drug Administration
Published: 2022-09-22

Class II · Ongoing

Class II FDA medical device recall by Hamilton Medical AG, initiated 2022-09-22. It names one FDA 510(k) clearance: K201658. Product: Hamilton-C6. Reason: 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..

Recalling firm: Hamilton Medical AG
Classification: Class II
Status: Ongoing
Initiated: 2022-09-22
Firm location: Domat/Ems, N/A, Switzerland

510(k) clearances named in this recall

1 on FDA's record

K201658 — Hamilton-C6Hamilton Medical AG·cleared 2020-12-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.