Hamilton-T1, REF: 161006, Intensive Care and Transport Ventilator
Summary
The FDA issued a Class I for Hamilton-T1, REF: 161006, Intensive Care and Transport 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-2526-2023
Action Date
2023-09-27
Status
Ongoing
Category
device
Product Description
Hamilton-T1, REF: 161006, Intensive Care and Transport Ventilator
Lot/Code Info: UDI: 07630002801850 & 07630002813532 / Affected Serial Numbers: 15929 17600 17661 17677 17698 17699 17741 17850 17877 17913 17925 17955 17957 17969 17975 17976 17982 17985 17986 17991 17993 17995 18009 18166 18183 18189 18191 18199 18224 18244 18251 18255 18256 18260 18263 18272 18273 18276 18288 18289 18305 18308 18333 18340 18349 18360 18363 18377 18378 18383 18414 18415 18419 18441 18451 18458 18461 18502 18537 18544 18550 18778 18784 19237 19290 19291 19292 19293 19294 19298 19304 19305 19470 19483 19490 26117
Quantity Affected: 76 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-2526-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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