FDA (Devices) recall action 89490
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.
A limited number of ventilators were assembled with expired adhesive. If the adhesive fails, a bracket may become loose and potentially damage the capacitors, which could cause the ventilator to stop providing ventilation to the patient. This failure may either activate both visual and audible alarms, or it may not sound or display an alarm (a silent shutdown).
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.
Respironics California is recalling 294 V60 Plus ventilators assembled with expired adhesive. The adhesive may fail, causing the bracket to loosen and damage capacitors, potentially stopping ventilation delivery.
A limited number of Philips Respironics V60 ventilators were assembled with expired adhesive. If the adhesive fails, the ventilator could stop providing ventilation.