Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported February 6, 2013
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
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…
Hamilton Medical Inc recalled HAMILTON-T1 Ventilator with software versions 1.1.2 or lower. The HAMILTON T-1 Vent… - a critical-severity action.
HAMILTON-T1 Ventilator with software versions 1.1.2 or lower. The HAMILTON T-1 Vent… was recalled by Hamilton Medical Inc in February 6, 2013. Reason: Analysis of a customer complaint has shown that during ventilation of small pediatric patients with high airw…. Check the official notice for the remedy. Verify recall #Z-0741-2013 with the FDA Devices before acting.
The recall
Hamilton Medical Inc issued this critical-severity FDA Devices recall-Analysis of a customer complaint has shown that during ventilation of small pediatric patients with high airw….
- Critical
- severity level
- Class I
- classification
- February 6, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0741-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0741-2013) was formally reported on February 6, 2013, with the manufacturer initiating the action on December 19, 2012. It is classified under Critical severity (Class I), with a current status of Terminated. Hamilton Medical Inc is listed as the recalling firm, operating out of Reno, NV. Federal records list the affected scope as 97 total ventilators; 69 of part number 161005 and 28 of part number 161006.
The documented reason for this recall is: 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 versio… Distribution data in the federal record shows the product reached: US Nationwide Distribution including the country of Switzerland.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
97 total ventilators; 69 of part number 161005 and 28 of part number 161006
Related Recalls
6
3 from same agency
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-0741-2013 |
| Date reported | February 6, 2013 |
| Date initiated | December 19, 2012 |
| Recalling firm | Hamilton Medical Inc |
| Firm location | Reno, NV |
| Affected scope | 97 total ventilators; 69 of part number 161005 and 28 of part number 161006 |
| Distribution | US Nationwide Distribution including the country of Switzerland. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0741-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Hamilton Medical Inc. Units affected: 97 total ventilators; 69 of part number 161005 and 28 of part number 161006.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 6, 2013. Severity: Critical. Recall number: Z-0741-2013.
Where was the recalled product distributed? ▼
Distribution: US Nationwide Distribution including the country of Switzerland..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0741-2013) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported February 6, 2013. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.