Hamilton-G5 Ventilators Recalled for Display Freeze Issue
Hamilton Medical is recalling 248 Hamilton-G5 ventilators because the display can freeze, preventing users from operating the device while ventilation continues.
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 high-risk medical device where a display freeze prevents user operation, creating a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Hamilton Medical, Inc. is recalling 248 Hamilton-G5 Ventilators with software versions V2.40 and 2.41. The affected devices are used for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients. The ventilators were distributed nationwide.
The recall is due to customer reports that the ventilator display can freeze. When this occurs, ventilation continues, but the information is no longer displayed on the screen, and the user can no longer operate the device.
Healthcare facilities should contact Hamilton Medical for instructions on how to resolve the issue. The agency has classified this as a Class II recall.
The recalled product
- Product
- Hamilton-G5 Ventilators with software versions V2.40/2.41 Catalog numbers for G5: 159001 and 159002. Software: 159700.. Intensive care ventilation of adult and pediatric patients and optionally infant and neonatal patients.
- Manufacturer
- Hamilton Medical, Inc.
- Category
- Medical Device — Ventilators
- Affected units
- 248
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)
- Software version 2.20 and 2.41
Distribution
Distributed nationwide across the United States.
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