Recall Z-1372-2018— Hamilton Medical AG
Class II · Ongoing
Class II FDA medical device recall by Hamilton Medical AG, initiated 2018-03-12. It names one FDA 510(k) clearance: K161450. Product: Hamilton-C3 Ventilator Unit Intended to provide ventilator support to adults and pediatrics and optionally infants and neonates in the hospital.. Reason: After two and a half years, the battery fuel gauge may indicate a higher battery charge than what is available..
- Recalling firm
- Hamilton Medical AG
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2018-03-12
- Firm location
- Bonaduz, Switzerland
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Hamilton-C3 Ventilator Unit Intended to provide ventilator support to adults and pediatrics and optionally infants and neonates in the hospital.
Reason for recall
After two and a half years, the battery fuel gauge may indicate a higher battery charge than what is available.
Data sourced from openFDA. This site is unofficial and independent of the FDA.