Hamilton C1/T1/MR1, REF: MSP161502/12, Control Board Spare part for ventilator
Summary
The FDA issued a Class I for Hamilton C1/T1/MR1, REF: MSP161502/12, Control Board Spare part for ventilator by Hamilton Medical, Inc.. Reason: Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control board causing a short circuit on the bo.
Details
Source
Device Recall
External ID
Z-2529-2023
Action Date
2023-09-27
Status
Ongoing
Category
device
Product Description
Hamilton C1/T1/MR1, REF: MSP161502/12, Control Board Spare part for ventilator
Lot/Code Info: UDI: 07630002805247 / Affected Serial Numbers: 4001901, 4002139, 4003445, 4003567, 4003576, 4005595
Quantity Affected: 6 units
Reason for Recall
Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control board causing a short circuit on the board and/or the capacitor to lose function and lead to interruption of ventilation.
Distribution
Distribution US nationwide, including Puerto Rico. OUS: Not provided
Type: Voluntary: Firm initiated
Recall Initiated: 2023-07-26
Company
Reno, NV
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 195 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Hamilton Medical, Inc. has 10 FDA actions in our database, including 10 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, Inc.) 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, Inc. have FDA actions?
Hamilton Medical, Inc. has 10 FDA actions in our database, including 10 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2529-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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