CLASS II Device recall · Reported 7 Dec 2016 · FDA Enforcement Report
Hamilton-MR1 Ventilator recalled by Hamilton Medical
Hamilton Medical is recalling Hamilton-MR1 Ventilator, distributed nationwide in the US. The recall was initiated on 26 Sep 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0666-2017
- FDA event ID
- 75336
- Recalling firm
- Hamilton Medical, Reno, NV
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Sep 2016
- FDA classified
- 28 Nov 2016
- Reported
- 7 Dec 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- CPAP & Ventilators
Timeline
| 26 Sep 2016 | Recall initiated by company | |
| 28 Nov 2016 | Classified by FDA | +63 days |
| 7 Dec 2016 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Oxygen tubing and the oxygen connector of the Hamilton-MR1 could potentially become loose during the preparation for ventilation.
Product as listed by the FDA
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.
Where it was distributed
Nationwide Distribution
Questions about this recall
Is Hamilton-MR1 Ventilator recalled?
Yes. Hamilton Medical recalled Hamilton-MR1 Ventilator on 26 Sep 2016. The recall is Class II and its status is Terminated. Recall number Z-0666-2017.
Why was it recalled?
Oxygen tubing and the oxygen connector of the Hamilton-MR1 could potentially become loose during the preparation for ventilation.
Which lots are affected?
Serial Numbers between 2001 and 2103
Where was it sold?
Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Hamilton Medical
All 20| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Hamilton-T1, REF: 161009, Intensive Care and Transport Ventilator recalled | Hamilton Medical | Lead & Heavy Metals | Nationwide |
| Device | CLASS I | Hamilton-T1, REF: MSP161339/02, ESM Shielding Set, Spare Part recalled | Hamilton Medical | Lead & Heavy Metals | Nationwide |
| Device | CLASS I | Hamilton-C1, REF: 161001, Portable Intensive Care Ventilator recalled | Hamilton Medical | Lead & Heavy Metals | Nationwide |
| Device | CLASS I | Hamilton-MR1, REF: 161010, Intensive Care Ventilator recalled | Hamilton Medical | Lead & Heavy Metals | Nationwide |
| Device | CLASS I | Hamilton-T1, REF: 161006, Intensive Care and Transport Ventilator recalled | Hamilton Medical | Lead & Heavy Metals | Nationwide |
Other CPAP & Ventilators recalls
All 552| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Hudson Rci, Dbd-circuit,Vent,Inspiratory,Heated,Neo recalled | Medline Industries | Device Malfunction | Nationwide |
| Device | CLASS II | Getinge Y Sensor Module, Servo-u, Servo-n recalled | Maquet Critical Care AB | Device Malfunction | Nationwide |
| Device | CLASS II | Biofire Respiratory Panel 1 (RP2.1) recalled by BioFire Diagnostics | BioFire Diagnostics | Other | Nationwide |
| Device | CLASS I | Astral 100/150 Resmed Astral 100/50 is a ventilator system recalled | ResMed | Packaging Defects | Nationwide |
| Device | CLASS I | Breathing circuit set, coaxial recalled by Hamilton Medical AG | Hamilton Medical AG | Device Malfunction | Nationwide |