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Recall Observatory FDA recall evidence

Device 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

Z-0741-2013

December 19, 2012

Class I

Product summary

Firm
Hamilton Medical Inc
Event
Event 64117
Status
Terminated
Classification
Class I
Quantity
97 total ventilators; 69 of part number 161005 and 28 of part number 161006
Official record key
device-enforcement:Z-0741-2013

Official wording

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.

Code information: Software Versions 1.1.2 and below; Part numbers 161005, 161006.

Distribution pattern: US Nationwide Distribution including the country of Switzerland.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.