FDA Medical Device Recalls (openFDA)
Hamilton Medical Inc: HAMILTON G5 ventilators with software version V2.0x. Hamilton Medical AG, Switzerland Imported and distributed by Hamilton Medical, 4990 Energy Way, Reno, NV 89502. Product Usage: Hamilton-G5 Ventilators are designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients. The devices are intended for use in the hospital and institutional environment with trained healthcare professionals.
- Recall number
- Z-1185-2012
- Recalling firm
- Hamilton Medical Inc
- Product
- HAMILTON G5 ventilators with software version V2.0x. Hamilton Medical AG, Switzerland Imported and distributed by Hamilton Medical, 4990 Energy Way, Reno, NV 89502. Product Usage: Hamilton-G5 Ventilators are designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients. The devices are intended for use in the hospital and institutional environment with trained healthcare professionals.
- Status
- Terminated
- Initiated
- 2012-02-06
- Posted
- 2012-03-07
- Terminated
- 2013-10-23
- Reason
- Hamilton-G5 ventilators with software version V2.0x may experience an unintentional change of the displayed ventilation mode under certain conditions.
- Root cause
- Software design
- Action
- Hamilton Medical sent a Medical Device Safety Alert and Correction Action letter dated February 17, 2011 to all affected customers via a traceable method. The letter identified the affected product, problem and immediate actions required by operators, distributor and manufacturer. The letter states that a Hamilton Medical Account manager will contact customers to schedule a convenient time for the Technical Support Department to install the software update. Questions or concerns may be directed to Technical Support Manager at 800-426-6331, Ext 125.
- Quantity
- 456 devices in US.
- Distribution
- (USA) Nationwide Distribution including the states of: CA, CO, FL, GA, MA, MI, MO, NC, NV, NY, PA, TN, TX, VA and WV.
- Lot, serial or model codes
- All Hamilton 5
- 510(k) numbers
- ["K103803"]
- PMA numbers
- not on file
- Product code
- CBK
- Firm FEI
- 2937708
- Firm city
- Reno
- Firm state
- NV
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28