Recall Z-0666-2017— Hamilton Medical, Inc.
Class II · Terminated
Class II FDA medical device recall by Hamilton Medical, Inc., initiated 2016-09-26, terminated 2017-03-08. It names one FDA 510(k) clearance: K122438. 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.. Reason: Oxygen tubing and the oxygen connector of the Hamilton-MR1 could potentially become loose during the preparation for ventilation..
- Recalling firm
- Hamilton Medical, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-09-26
- Terminated
- 2017-03-08
- Firm location
- Reno, NV, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
Oxygen tubing and the oxygen connector of the Hamilton-MR1 could potentially become loose during the preparation for ventilation.
Data sourced from openFDA. This site is unofficial and independent of the FDA.