FDA (Devices) recall action 97861
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.
The heat function may become damaged over time due to patients pressing on the areas with heat function components. Damage to components can lead to overheating which can lead to smoldering and melting of the vinyl cushion.
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.
Pivotal Health Solutions is recalling 464 Quantum Intersegmental Tables because damage to the heat function components can lead to overheating, smoldering and melting of the vinyl cushion.
Pivotal Health Solutions is recalling 34 Quantum Intersegmental Tables, model Q400, because damage to the heat function components can lead to overheating and smoldering.