Recall Z-1874-2019— Hamilton Medical AG

Name: FDA recall Z-1874-2019
Creator: U.S. Food and Drug Administration
Published: 2019-03-25

Class I · Terminated

Class I FDA medical device recall by Hamilton Medical AG, initiated 2019-03-25, terminated 2024-06-03. It names 3 FDA 510(k) clearances: K131774, K103803, K081521. Product: HAMILTON-G5, with software versions less than or equal to 2.60 The HAMILTON-G5/S1 ventilators are designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients. The device is intended for use in the hospital and institutional environment where health care professionals provide patient care.. Reason: New software version for affected ventilators reduces the probability of the ventilator entering an ambient state, in which the inspiratory channel and expiratory valves are opened, letting the patient breathe room air unassisted. When the ventilator enters the ambient state, alternative ventilation must be provided immediately..

Recalling firm: Hamilton Medical AG
Classification: Class I
Status: Terminated
Initiated: 2019-03-25
Terminated: 2024-06-03
Firm location: Bonaduz, Switzerland

510(k) clearances named in this recall

3 on FDA's record

K131774 — HAMILTON-G5Hamilton Medical AG·cleared 2013-10-09
K103803 — HAMILTON-G5Hamilton Medical AG·cleared 2011-11-23
K081521 — MODIFICATION TO HAMILTON-G5Hamilton Medical AG·cleared 2008-09-25

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-G5, with software versions less than or equal to 2.60 The HAMILTON-G5/S1 ventilators are designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients. The device is intended for use in the hospital and institutional environment where health care professionals provide patient care.

Reason for recall

New software version for affected ventilators reduces the probability of the ventilator entering an ambient state, in which the inspiratory channel and expiratory valves are opened, letting the patient breathe room air unassisted. When the ventilator enters the ambient state, alternative ventilation must be provided immediately.

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