The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0267-2023·Announced 2022-11-30

Ventilator Screen Backlight Malfunction Causes Temporary Display Loss

Hamilton-C6 ventilators are subject to a backlight malfunction causing the display screen to go black for 2-3 seconds. The FDA has classified this Class II recall as affecting 443 U.S. systems distributed nationwide.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II medical device recall affecting a critical care ventilator. While no injuries or hospitalizations have been reported, the screen visibility malfunction poses a potential risk-of-harm by temporarily obscuring critical patient information on a life-support device used in critical care settings.

Plain-English summary

Hamilton Medical AG is recalling the Hamilton-C6 ventilator due to a malfunction of the backlight on the display screen. The defect causes the screen to go black for approximately 2-3 seconds before the backlight switches back on and the display brightens again.

In the United States, 443 systems are subject to this recall. The affected units are distributed nationwide across 24 states and Puerto Rico. Worldwide, 8,229 systems are affected. The recall applies to Model 160021 ventilators with specific serial numbers identified in the official recall notice.

The FDA classified this recall as Class II. The temporary loss of screen visibility during the backlight malfunction may impair the ability of clinicians to view critical patient information and device status during the blackout periods.

The recalled product

Product
Hamilton-C6
Manufacturer
Hamilton Medical AG
Category
Medical Device — Ventilator / Respiratory Equipment
Hazard

Distribution

Distributed nationwide across the United States.

The notice also names 24 states specifically:

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