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Terminated

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.

FDA Recall Z-2057-2015 · Posted 2015-07-10

Recalling FirmHamilton Medical, Inc.
Recall StatusTerminated
Product CodeCBK
Date Initiated2015-03-24
Date Terminated2015-12-23
Product Quantity248

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.

Firm Action

*** Please note *** This is not a new recall. An error occurred, and this recall was originally classified as a class I on July 10, 2015. No further action is required. Hamilton Medical AG notified their customers with a letter dated February 19, 2015 and had a fix (SW 2.42) that was available as of February 20th 2015. Hamilton Medical proceeded to send out notification letters the 24th of March 2015 once they compiled the complete and validated list of customers that had the affected software. Customers with questions were instructed to call 800-426-6331, ext.215.

Root Cause

Device Design

Distribution Pattern

Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K131774HAMILTON-G5Hamilton Medical AG · 2013-10-09K103803HAMILTON-G5Hamilton Medical AG · 2011-11-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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