Hamilton Medical Recalls MR1 Ventilators Due to Oxygen Tubing Loosening Risk
Hamilton Medical is recalling 44 MR1 ventilators because the oxygen tubing and connector could become loose during preparation, potentially compromising ventilation support.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where a mechanical defect could compromise life-support ventilation. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Hamilton Medical, Inc. is recalling 44 units of the Hamilton-MR1 Ventilator (Catalog # 161010). The affected devices are identified by serial numbers between 2001 and 2103. These ventilators are intended to provide pressure ventilator support to adults, pediatrics, and optionally infants and neonates in various hospital settings, including MRI departments, intensive care, and emergency rooms.
The recall was initiated because the oxygen tubing and the oxygen connector of the Hamilton-MR1 could potentially become loose during the preparation for ventilation. This issue could affect the integrity of the ventilation support provided to patients.
The affected units were distributed nationwide. Healthcare facilities and users of these devices should contact Hamilton Medical for further instructions on how to address the issue.
The recalled product
- 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…
- Manufacturer
- Hamilton Medical, Inc.
- Category
- Medical Device — Ventilator
- Affected units
- 44
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Serial Numbers between 2001 and 2103
Distribution
Distributed nationwide across the United States.
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