HAMILTON-T1 Ventilator with software versions 1 — Class I medical device recall Z-0741-2013
Terminated recall by Hamilton Medical Inc, reported 2013-02-06, distributed nationwide. Analysis of a customer complaint has shown that during ventilation of small pediatric patients with high airwa
| Recall number | Z-0741-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hamilton Medical Inc, Reno, NV, United States |
| Recall initiated | 2012-12-19 |
| Classified | 2013-01-31 |
| Reported by FDA | 2013-02-06 |
| Terminated | 2014-04-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | CH |
| Reason classes | software |
| Model numbers | 161005, 161006 |
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 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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.