FDA Medical Device Recalls (openFDA)
Hamilton Medical, Inc.: Hamilton-MR1 Ventilator: Catalog# 161010 The Hamilton MR1 Ventilator is intended to provide pressure ventilator support to adults and pediatrics, and optionally infants and neonates. Intended areas of use include: MRI Dept., Intensive, intermediate, emergency and long-term acute care as well as transfer of patients within a hospital.
- Recall number
- Z-0666-2017
- Recalling firm
- Hamilton Medical, Inc.
- Product
- Hamilton-MR1 Ventilator: Catalog# 161010 The Hamilton MR1 Ventilator is intended to provide pressure ventilator support to adults and pediatrics, and optionally infants and neonates. Intended areas of use include: MRI Dept., Intensive, intermediate, emergency and long-term acute care as well as transfer of patients within a hospital.
- Status
- Terminated
- Initiated
- 2016-09-26
- Posted
- 2016-11-28
- Terminated
- 2017-03-08
- Reason
- Oxygen tubing and the oxygen connector of the Hamilton-MR1 could potentially become loose during the preparation for ventilation.
- Root cause
- Device Design
- Action
- Hamilton Medical sent a letter dated September 6, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Hamilton Medical will update each affected Hamilton-MR1 ventilators by installing a new oxygen mixer mounting plate with the correct screws at no cost to each facility. A Hamilton Medical Field Service Technician will contact customers soon to schedule a convenient time to install the hardware upgrade. Customers may also call 1-800-426-6331, option #2 to be issued an RGA for return to the service center for the upgrade kit to be installed. Customers with questions should call 817-909-0308.
- Quantity
- 44 units
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Serial Numbers between 2001 and 2103
- 510(k) numbers
- ["K122438"]
- 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