FDA (Devices) recall action 71583
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.
Potential missing segments on the display that can result in misinterpretation of data.
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.
FDA is recalling OxiMax N-65 handheld pulse oximeters because missing display segments may cause users to misinterpret oxygen saturation and pulse rate data.
The FDA is recalling OxiMax N-560 Pulse Oximeters because missing display segments may cause users to misinterpret oxygen saturation and pulse rate data.