Class I recallOngoing

Hamilton C6 recall — FDA event 97079

FDA · FDA event 97079 · Posted Aug 19, 2025

Published Aug 19, 2025Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

What happened

A mechanical defect on a printed circuit board (PCB) as a result of PCB separating process. This defect might cause the ventilator to either fail at startup (no patient involvement) or during the use of the device enter ambient state, resulting in an interruption of ventilation.

Who may be affected

People using a product, model, software version, lot, or UDI listed in the affected-products table and official FDA record.
A mention of the device family does not mean every unit is affected. Compare the identifiers on your product with the official source.

What the official notice recommends

URGENT: Medical Device Correction letters were emailed to customers on 06/06/2025, 06/20/2025, and 07/07/2025, informing them that due to damage to the capacitor in the ESM-Board within the Hamilton-C6 ventilator the capacitor could, over time, lead to a loss of its function due to oxidation of similar degradation processes.
Customers are instructed to: 1. Review their Hamilton-C6 ventilators and check for the serial number within the scope mentioned in the letter. 2. for affected ventilators must have the ESM-Boards replaced. The replacement will be organized by the local partner as per servicing protocol. Note - the Hamilton-C6 ventilators do not need to be removed from use/service. These devices were tested prior to release and no test will be able to detect if the ESM board will fail in the future. 3. Keep the recall notice within the respective ventilator's data records.
For questions or assistance, contact Technical Support at 1-800-426-6331 option 2 or email reno.techsupport@hamiltonmedical.com

The official notice takes precedence over this summary. Talk to your clinician before changing prescribed therapy.

Affected products and models

This FDA record lists Hamilton C6 by Hamilton Medical AG.

Products affected by FDA event 97079
Model	Description	Lot / serial range	Manufactured	Status
Z-2328-2025	Z-2328-2025	Model/Catalog Number: 160021 ESM board Part Number: 10144626 GTIN: 07630002808590 UDI-DI: 76300028PN160021ZW Affected SN range: 13636 till 13950 and 13966 till 14753 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	Not provided in the normalized record	Ongoing

Distribution: US Nationwide distribution.
Units affected: See official FDA record
Category: Ventilators

Timeline

Jun 3, 2025
Recall initiated
Date recorded by the FDA.
Aug 19, 2025
Posted by FDA
The recall event appeared in the FDA source.
Oct 8, 2026
Last checked
MedWatcher last reconciled this record with the openFDA export.

Primary source

U.S. Food and Drug Administration

Identifier: 97079
Published: Aug 19, 2025
Source checked: 2026-10-08 16:03:16 UTC

Official openFDA device-recall record. The FDA source takes precedence over this normalized summary.

View official record

How MedWatcher checks these sources

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Due to a Supercapacitor electrolyte leakage on Printed Circuit Board Assembly (PCBA) may damage the charger chip, causing fail-safe state and interruption of ventilation therapy.

FDA · FDA event 99304Posted Jul 28, 2026

Class II recallOngoing

VOCSN+Pro package recall — FDA event 98888

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FDA · FDA event 98888Posted Jun 23, 2026

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Hamilton C6 recall — FDA event 97079

FDA · FDA event 97079 · Posted Aug 19, 2025

Published Aug 19, 2025Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

Affected products and models

This FDA record lists Hamilton C6 by Hamilton Medical AG.

Products affected by FDA event 97079
Model	Description	Lot / serial range	Manufactured	Status
Z-2328-2025	Z-2328-2025	Model/Catalog Number: 160021 ESM board Part Number: 10144626 GTIN: 07630002808590 UDI-DI: 76300028PN160021ZW Affected SN range: 13636 till 13950 and 13966 till 14753 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	Not provided in the normalized record	Ongoing

Distribution

US Nationwide distribution.

Units affected

See official FDA record

Resmed Astral 100/150 Resmed Astral 100/50 recall — FDA event 99304

Due to a Supercapacitor electrolyte leakage on Printed Circuit Board Assembly (PCBA) may damage the charger chip, causing fail-safe state and interruption of ventilation therapy.

FDA · FDA event 99304Posted Jul 28, 2026

Class II recallOngoing

VOCSN+Pro package recall — FDA event 98888

FDA · FDA event 98888Posted Jun 23, 2026

Class I recallOngoing

VOCSN V+Pro package recall — FDA event 98554

FDA · FDA event 98554Posted May 1, 2026

Hamilton C6 recall — FDA event 97079

Follow Hamilton C6

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

Hamilton C6 recall — FDA event 97079

Follow Hamilton C6

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline