Recall – Ventilator error may cause unit to permanently enter ambient state

Company: Hamilton Medical
Date of Enforcement Report: 7/12/2019
Class I

PRODUCT

Hamilton Medical AG Hamilton-G5 Ventilator (PN 159001)

Recall Number: Z-1874-2019

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/MANUFACTURER

Hamilton Medical on 3/25/2019. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
4338 units

DISTRIBUTION

US Nationwide and International

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.