Summary
The FDA issued a Class I for Ventilator HAMILTON-C6, PN: 160021 by Hamilton Medical AG. Reason: Ventilator may enter sensor fail mode, ventilation may not re-initiate, after patient is reconnected, which may cause hypoxia, if this sequence occurs.
Details
Source
Device Recall
External ID
Z-2020-2024
Action Date
2024-06-26
Status
Ongoing
Category
device
Product Description
Ventilator HAMILTON-C6, PN: 160021
Lot/Code Info: UDI: 07630002808590, Software Versions: SW v1.1.4, SW v1.1.5, SW v1.1.6
Quantity Affected: 68
Reason for Recall
Ventilator may enter sensor fail mode, ventilation may not re-initiate, after patient is reconnected, which may cause hypoxia, if this sequence occurs: 1)User presses O2 enrichment, 2)User disconnects endotracheal tube for open suctioning, 3)Sensor error initiated, sensor fail mode occurs, 4)Patient is re-connected with sensor fail mode active, 5) Ventilation is not re-initiated by the ventilator.
Distribution
US Nationwide distribution in the states of GA, KY, FL, IN, NV, MI, VA, OR, TX, SC, CA, PA.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-05-15
Company
Bonaduz, N/A
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 115 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Hamilton Medical AG has 7 FDA actions in our database, including 7 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Hamilton Medical AG) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Hamilton Medical AG have FDA actions?
Hamilton Medical AG has 7 FDA actions in our database, including 7 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2020-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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