Hamilton-C6
FDA Recall Z-0267-2023 · Posted 2022-11-18
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Recalling FirmHamilton Medical AG
Recall StatusOpen, Classified
Product CodeCBK
Date Initiated2022-09-22
Product Quantity8,229 total systems worldwide (U.S. 443 systems)
Reason for Recall
Due to a malfunction related to the backlight on the ventilator screen. The screen goes black for approximately 2-3 seconds, but it brightens up again when the backlight switches on again.
Firm Action
On 10/19/2022, Hamilton Medical, Inc. sent an "URGENT - Medical Device Correction" Letter via email to customers informing them the firm had received a complaint report associated with the backlight of the HAMILTON C-6 display failing. The failure is attributed to a reset of the HMI controller reset with causes the display to fail for 2-3 seconds. Hamilton Medical is notifying customer that this failure does not affect or interrupt the device's ventilation function.
Customers are instructed to:
-Sign the enclosed sheet confirming that they have received and understood this Medical Device Correction. Also, continue to notify their local distribution partner of any cases of the aforementioned malfunction. No further action on their part is required.
-Keep this information sheet with your HAMILTON-C6 Operator's Manual and prominently displayed as a constant reminder to the device users.
For questions, contact -
Hamilton Medical AG
Technical Support
Parc Industrial Vial 10
CH-7013 Domat/Ems
Switzerland
Tel. +41 58 610 10 20
e-mail: [email protected]
Root Cause
Under Investigation by firm
Distribution Pattern
U.S. Nationwide distribution including in the states of CA, FL, GA, ID, IN, KS, KY, MA, MI, MO, NV, NM, NY, NC, OH, PA, Puerto Rico, SC, TX, VA, WA, WV, WI, and WY.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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