Summary
The FDA issued a Class II for HAMILTON-C6, REF: 160021 by Hamilton Medical AG. Reason: Software error causes, safety ventilation, in which ventilation continues in the "safety ventilation" mode with audible/visible alarm - patient inputs.
Details
Source
Device Recall
External ID
Z-1429-2023
Action Date
2023-05-03
Status
Ongoing
Category
device
Product Description
HAMILTON-C6, REF: 160021
Lot/Code Info: Software Version: 1.2.1, UDI-DI: 07630002808590
Quantity Affected: 103
Reason for Recall
Software error causes, safety ventilation, in which ventilation continues in the "safety ventilation" mode with audible/visible alarm - patient inputs are not monitored, if the following coincide 1) A mode change to an adaptive mode (ASV, APVcmv, APVsimv, INTELLiVENT-ASV, (S)CMV+, SIMV+), and 2) The controller and/or humidifier is connected to the ventilator and is operational.
Distribution
US Nationwide distribution in the states of CA, MA, ID, NC, GA, FL, NV, PA, MO, KS, SC, NY, NM, WY, VA.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-03-14
Company
Bonaduz, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 122 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 II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
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-1429-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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