Severity
Critical
CriticalClass IOngoing
FDA Devices recall · Reported August 2, 2023
HAMILTON C3 Ventilator REF 160005 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates
Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior notice.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Hamilton Medical, Inc. recalled HAMILTON C3 Ventilator REF 160005 Is intended to provide positive pressure ventilator… - a critical-severity action.
HAMILTON C3 Ventilator REF 160005 Is intended to provide positive pressure ventilator… was recalled by Hamilton Medical, Inc. in August 2, 2023. Reason: Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter th…. Check the official notice for the remedy. Verify recall #Z-2142-2023 with the FDA Devices before acting.
The recall
Hamilton Medical, Inc. issued this critical-severity FDA Devices recall-Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter th….
- Critical
- severity level
- Class I
- classification
- August 2, 2023
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2142-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2142-2023) was formally reported on August 2, 2023, with the manufacturer initiating the action on June 15, 2023. It is classified under Critical severity (Class I), with a current status of Ongoing. Hamilton Medical, Inc. is listed as the recalling firm, operating out of Reno, NV. Federal records list the affected scope as 701 systems.
The documented reason for this recall is: Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior notice. Distribution data in the federal record shows the product reached: U.S.: Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Mis…. 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
701 systems
Related Recalls
6
3 from same agency
Product description
HAMILTON C3 Ventilator REF 160005 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates
Reason for recall
Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior notice.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-2142-2023 |
| Date reported | August 2, 2023 |
| Date initiated | June 15, 2023 |
| Recalling firm | Hamilton Medical, Inc. |
| Firm location | Reno, NV |
| Affected scope | 701 systems |
| Distribution | U.S.: Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebras… |
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-2142-2023) 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 C3 Ventilator REF 160005 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates. Recalled by Hamilton Medical, Inc.. Units affected: 701 systems.
Why was this product recalled? ▼
Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior notice.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 2, 2023. Severity: Critical. Recall number: Z-2142-2023.
Where was the recalled product distributed? ▼
Distribution: U.S.: Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin Wyoming Added 08/30/2023 - Puerto Rico O.U.S.: Bahamas, Japan and Mexico.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2142-2023) 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 August 2, 2023. 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.