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Use caution Medical device recall · FDA · Published June 3, 2025

Hamilton C6 Ventilator Recall: PCB Defect May Cause Ventilation Interruption

Hamilton Medical recalls C6 ventilators with specific serial numbers due to a PCB defect that can cause ventilation failure. Affected units may stop working during use, risking interrupted breathing support.

🇺🇸 FDA recall #Z-2328-2025Medical deviceHamilton Medical ›
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Recalling firmHamilton Medical AGParc Industrial Vial 10 · Domat/Ems, Switzerland
✎ GovInfoNow plain-language explainer

Hamilton Medical is recalling certain C6 ventilators because a defect in the printed circuit board could cause the device to stop working during use, potentially interrupting breathing support. This is serious for patients who rely on the ventilator for life support. Read more at govinfonow.com/recall/52164-hamilton-c6-ventilator-recall-pcb-defect-may-cause-ventilation-interruption.

Source Summary by GovInfoNow · govinfonow.com/recall/52164-hamilton-c6-ventilator-recall-pcb-defect-may-cause-ventilation-interruption · Updated August 18, 2026 · FDA enforcement record: FDA #Z-2328-2025

Cite this page

“Hamilton C6 Ventilator Recall: PCB Defect May Cause Ventilation Interruption.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52164-hamilton-c6-ventilator-recall-pcb-defect-may-cause-ventilation-interruption. Based on FDA recall #Z-2328-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2328-2025%22&limit=1).

The FDA announced on June 3, 2025, that Hamilton Medical AG is voluntarily recalling the Hamilton C6 ventilator due to a mechanical defect that may cause ventilation interruption. Owners should contact the company for remedy details.

How to tell if you have it

  • Hamilton C6 REF 160021
  • ESM Board PN 10144626
  • UDI-DI code: 76300028PN160021ZW
  • UPC 07630002808590
  • Affected SN range: 13636 till 13950 and 13966 till 14753
  • Affected SNs: 13797, 13801, 13806, 13855, 13865, 13981, 13988, 13989, 14012, 14015, 14019, 14034, 14035, 14042, 14052, 14054, 14102, 14109, 14112, 14113, 14114, 14115, 14116, 14119, 14120, 14121, 14122, 14123, 14124, 14126, 14127, 14128, 14163, 14168, 14169, 14170, 14172, 14173, 14175, 14177, 14187, 14188, 14189, 14195, 14197

The hazard

A mechanical defect on a printed circuit board (PCB) resulting from the PCB separating process may cause the ventilator to fail at startup or enter an ambient state during use. This defect can result in an interruption of ventilation, according to the FDA.

Context

GovInfoNow's records show Hamilton Medical AG has 11 other recalls on record since March 9, 2018. Other recent recalls of similar products include Hamilton Medical Breathing Circuit Sets Risk: Exhalation Obstruction During Ventilation (May 29, 2026), Hamilton Medical IntelliCuff Recall: Cuff System Leakage Error Risk (May 22, 2026), and Hamilton Medical Breathing Circuit Recall: Crack Risk of Rebreathing Gases (June 26, 2025). Other recent recalls of similar products include Baxter Blue Ventilator Adapter Module Recall: Oxygen Desaturation Risk (Feb. 18, 2026), ResMed Astral Ventilators Recall: Supercapacitor Leak Risks Ventilation Failure (June 25, 2026), and GE Healthcare Carestation Anesthesia System Power Board Recall: Risk of Ventilation Disruption (Nov. 14, 2025).

How to tell if you have this one

Check the serial number on the ventilator's label. Affected units have serial numbers from 13636 to 13950 and 13966 to 14753, including specific numbers like 13797, 13801, and 13806.

  • Brand
    Hamilton Medical
  • Product
    Hamilton C6 REF 160021 (ESM Board PN 10144626 UDI-DI code: 76300028PN160021ZW Hamilton C6 is a ventilator intended to
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Serial Number

    Look for the serial number on the ventilator's label to determine if it falls within the affected range of 13636 to 13950 or 13966 to 14753.

  2. Contact Manufacturer

    If your ventilator is affected, contact Hamilton Medical directly for further instructions on how to address the issue.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 3 months after the firm started it.

1. Firm started the recall: Jun 3, 202512. FDA classified it Class I: Aug 19, 202523. Published in FDA’s Enforcement Report: Aug 27, 202532025
  1. Firm started the recall
  2. FDA classified it Class I
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2328-2025 (June 3, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2328-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA