Recall Z-1385-2022— Hamilton Medical AG

Name: FDA recall Z-1385-2022
Creator: U.S. Food and Drug Administration
Published: 2021-01-05

Class III · Completed

Class III FDA medical device recall by Hamilton Medical AG, initiated 2021-01-05. It names one FDA 510(k) clearance: K163283. Product: HAMILTON-H900 Humidifier, Models: 950001, 950004. Reason: When starting a humidifier, intended for respiratory gas conditioning during invasive and noninvasive mechanical ventilation, with an empty chamber, and water is not filled into the chamber, the low water level alarm will be delayed and medical staff are unaware that there is no water in the chamber..

Recalling firm: Hamilton Medical AG
Classification: Class III
Status: Completed
Initiated: 2021-01-05
Firm location: Bonaduz, Switzerland

510(k) clearances named in this recall

1 on FDA's record

K163283 — HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010Hamilton Medical AG·cleared 2017-09-20

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-H900 Humidifier, Models: 950001, 950004

Reason for recall

When starting a humidifier, intended for respiratory gas conditioning during invasive and noninvasive mechanical ventilation, with an empty chamber, and water is not filled into the chamber, the low water level alarm will be delayed and medical staff are unaware that there is no water in the chamber.

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