Recall Z-2057-2015— Hamilton Medical, Inc.

Name: FDA recall Z-2057-2015
Creator: U.S. Food and Drug Administration
Published: 2015-03-24

Class II · Terminated

Class II FDA medical device recall by Hamilton Medical, Inc., initiated 2015-03-24, terminated 2015-12-23. It names 2 FDA 510(k) clearances: K131774, K103803. Product: Hamilton-G5 Ventilators with software versions V2.40/2.41 Catalog numbers for G5: 159001 and 159002. Software: 159700.. Intensive care ventilation of adult and pediatric patients and optionally infant and neonatal patients.. Reason: Customer reports that the ventilator display can freeze. Ventilation continues but the information is no longer displayed on the screen and the user can no longer operate the device..

Recalling firm: Hamilton Medical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-03-24
Terminated: 2015-12-23
Firm location: Reno, NV, United States

510(k) clearances named in this recall

2 on FDA's record

K131774 — HAMILTON-G5Hamilton Medical AG·cleared 2013-10-09
K103803 — HAMILTON-G5Hamilton Medical AG·cleared 2011-11-23

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 Ventilators with software versions V2.40/2.41 Catalog numbers for G5: 159001 and 159002. Software: 159700.. Intensive care ventilation of adult and pediatric patients and optionally infant and neonatal patients.

Reason for recall

Customer reports that the ventilator display can freeze. Ventilation continues but the information is no longer displayed on the screen and the user can no longer operate the device.

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