The Recall Desk
HighFDA (Devices)·Z-1372-2018·Announced 2018-04-18

Hamilton-C3 Ventilator Battery Fuel Gauge Recall

Hamilton Medical AG is recalling 739 Hamilton-C3 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 medical device where a power gauge error could lead to unexpected loss of ventilator support, representing a risk of harm even though no specific injuries or illnesses are reported in the source text.

Plain-English summary

Hamilton Medical AG is recalling 739 Hamilton-C3 Ventilator Units. These devices are intended to provide ventilator support to adults, pediatrics, and optionally infants and neonates in the hospital setting.

The recall is being issued because, after two and a half years, the battery fuel gauge may indicate a higher battery charge than what is actually available. This discrepancy could affect the reliability of the device's power status display.

The affected units are distributed worldwide, including in the United States and numerous international countries. The recall applies to Product No. 160005 with all serial numbers. Users should contact Hamilton Medical AG for further instructions on how to address this issue.

The recalled product

Product
Hamilton-C3 Ventilator Unit Intended to provide ventilator support to adults and pediatrics and optionally infants and neonates in the hospital.
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. 160005 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.

See all 2 products in this recall →