Enforcement Report - Week of February 6, 2013
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Event Detail
| Event ID | 64117 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Hamilton Medical Inc |
| City | Reno |
| State | NV |
| Country | US |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2013-01-11 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | US Nationwide Distribution including the country of Switzerland. |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| 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 | Software Versions 1.1.2 and below; Part numbers 161005, 161006. | Class I | 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. | 97 total ventilators; 69 of part number 161005 and 28 of part number 161006 | Z-0741-2013 |
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