Hamilton-C6

FDA device recall Z-0267-2023 · posted 2022-11-18 · Open, Classified

Recall details

Recalling firm

Hamilton Medical AG

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.

Action taken

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: techsupport@hamilton-medical.com

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

CBK

Quantity affected

8,229 total systems worldwide (U.S. 443 systems)

Distribution

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.

Date initiated

2022-09-22

Date posted

2022-11-18

Location

Domat/Ems, Switzerland

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