Recall Z-0741-2013— Hamilton Medical Inc
Class I · Terminated
Class I FDA medical device recall by Hamilton Medical Inc, initiated 2012-12-19, terminated 2014-04-22. It names one FDA 510(k) clearance: K120670. Product: HAMILTON-T1 Ventilator with software versions 1.1.2 or lower. The HAMILTON T-1 Ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics. Reason: Analysis of a customer complaint has shown that during ventilation of small pediatric patients with high airway resistance and low lung compliance, the oxygen consumption of a Hamilton T1 ventilator with software versions 1.1.2 and lower must be calculated using a larger margin than originally expected..
- Recalling firm
- Hamilton Medical Inc
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2012-12-19
- Terminated
- 2014-04-22
- Firm location
- Reno, NV, United States
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-T1 Ventilator with software versions 1.1.2 or lower. The HAMILTON T-1 Ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics
Reason for recall
Analysis of a customer complaint has shown that during ventilation of small pediatric patients with high airway resistance and low lung compliance, the oxygen consumption of a Hamilton T1 ventilator with software versions 1.1.2 and lower must be calculated using a larger margin than originally expected.
Data sourced from openFDA. This site is unofficial and independent of the FDA.