FDA Device recall Z-0741-2013
HAMILTON-T1 Ventilator with software versions 1.1.2 or lower
- FDA Device
- Class I
- terminated
- Published 2013-02-06
On 2013-02-06 the FDA classified a Class I recall of HAMILTON-T1 Ventilator with software versions 1.1.2 or lower by Hamilton Medical, citing 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 Ham….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0741-2013 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2012-12-19 |
| Published | 2013-02-06 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Hamilton Medical |
| Distribution | US |
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.
Identifiers
| code_info | Software Versions 1.1.2 and below; Part numbers 161005, 161006. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0741-2013%22
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