Hamilton-C2 Ventilator Units Recalled Due to Battery Fuel Gauge Inaccuracy
Hamilton Medical AG is recalling 739 Hamilton-C2 Ventilator Units worldwide because the battery fuel gauge may inaccurately indicate a higher charge than available.
What this means for you
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 critical medical device (ventilator) where a battery gauge error poses a risk of harm to patients, but no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Hamilton Medical AG is recalling 739 Hamilton-C2 Ventilator Units. These devices are intended to provide ventilator support to adults, pediatrics, and optionally infants and neonates in hospital settings. The recall covers Product No. 160001 with all serial numbers.
The recall is being conducted because, after two and a half years of use, the battery fuel gauge may indicate a higher battery charge than what is actually available. This inaccuracy could potentially affect the device's ability to provide continuous ventilator support if the battery is depleted unexpectedly.
The affected units were distributed worldwide, including in the United States and numerous international countries. Healthcare facilities and users should contact Hamilton Medical AG for instructions on how to address the battery gauge issue.
The recalled product
- Product
- Hamilton-C2 Ventilator Unit Intended to provide ventilator support to adults and pediatrics and optionally infants and neonates in the hospital.
- Manufacturer
- Hamilton Medical AG
- Category
- Medical Device — Ventilator
- Affected units
- 739
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)
- Product No. 160001 All Serial Numbers.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Hamilton Medical AG under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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