Hamilton G5 Ventilator Recalled for Suctioning Maneuver Software Defect
Hamilton Medical is recalling 1,115 Hamilton G5 ventilators because the ventilation pattern may not continue as expected after a suctioning maneuver.
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 is classified as FDA Class II, and the hazard involves a critical life-support device (ventilator) failing to maintain expected ventilation patterns, which poses a risk of harm to patients even though specific injuries are not reported in the text.
Plain-English summary
Hamilton Medical, Inc. is recalling 1,115 units of the Hamilton G5 ventilator (catalog numbers 1590001 and 1590002) with software versions between v2.41, v2.42, and v2.50. The devices are intended for intensive care ventilation of adult and pediatric patients, and optionally infants and neonatal patients, in hospital and institutional environments.
The recall is due to a software defect where the preset pattern of ventilation may not continue as expected after performing a suctioning maneuver, which includes disconnecting the patient, suctioning, and reconnecting the patient. This issue affects devices distributed in the United States.
Healthcare facilities should check their inventory for the affected serial numbers listed in the recall notice. Hamilton Medical is the recalling firm responsible for addressing this issue.
The recalled product
- Product
- Hamilton G5 with software version between v2.41, v2.42, v2.50. Catalog number: 1590001 and 1590002. Anesthesiology: Hamilton G5 ventilator is designed for intensive care ventilation of adult and pediatric patients, and optionally infants and neonatal patients. The device is…
- Manufacturer
- Hamilton Medical, Inc.
- Category
- Medical Device — Ventilator
- Affected units
- 1,115
Distribution
Distribution scope not specified by the agency.
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