FDA (Devices) recall action 78599
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
After two and a half years, the battery fuel gauge may indicate a higher battery charge than what is available.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Hamilton Medical AG is recalling 739 Hamilton-C3 Ventilator Units worldwide because the battery fuel gauge may inaccurately indicate a higher charge than available.
Hamilton Medical AG is recalling 739 Hamilton-C2 Ventilator Units worldwide because the battery fuel gauge may inaccurately indicate a higher charge than available.