Z-0666-2017Class II

Hamilton-MR1 Ventilator: Catalog# 161010 The Hamilton MR1 Ventilator is intended to provide pressure...

Name: Z-0666-2017 Hamilton-MR1 Ventilator: Catalog# 161010 The Hamilton MR1 Ventilator is intended to provide pressure...
Creator: Hamilton Medical, Inc.
Published: 2016-09-26
License: https://open.fda.gov/license/

Hamilton Medical AG / initiated 2016-09-26 / Terminated / root cause: design

FDA source

Hamilton Medical, Inc. began a recall of Hamilton-MR1 Ventilator: Catalog# 161010 The Hamilton MR1 Ventilator is intended to provide pressure ventilator support to adults and pediatrics, and... on 2016-09-26. FDA classified it as Class II and gives the reason as "Oxygen tubing and the oxygen connector of the Hamilton-MR1 could potentially become loose during the preparation for ventilation". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0666-2017
Classification: Class II
Status: Terminated
Initiated: 2016-09-26
Posted: 2016-11-28
Terminated: 2017-03-08
Recalling firm: Hamilton Medical AG
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.
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: Oxygen tubing and the oxygen connector of the Hamilton-MR1 could potentially become loose during the preparation for ventilation.
Root cause tag: design
FDA 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 in commerce: 44 units
Distribution: Nationwide Distribution
Product codes and lots: Serial Numbers between 2001 and 2103

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0666-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0666-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-07	2016-11-28

Product code CBK

K122438Class IIHamilton-Mr1Hamilton Medical AG / cleared 2013-11-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)