Hamilton-MR1 Ventilator: Catalog# 161010 The Hamilton MR1 Ventilator is intended to provide pressure ventilator support
FDA device recall Z-0666-2017 · posted 2016-11-28 · Terminated
Recall details
- Recalling firm
- Hamilton Medical, Inc.
- Reason for recall
- Oxygen tubing and the oxygen connector of the Hamilton-MR1 could potentially become loose during the preparation for ventilation.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- CBK
- Quantity affected
- 44 units
- Distribution
- Nationwide Distribution
- Date initiated
- 2016-09-26
- Date posted
- 2016-11-28
- Date terminated
- 2017-03-08
- Location
- Reno, NV
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HAMILTON-MR1 (K122438) | Hamilton Medical AG | 2013-11-20 |