FDA (Devices) recall action 94170
The FDA (Devices) publishes a recall like this one as 4 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 4 pages.
Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
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.
Masimo Corporation is recalling 443 Rad-G pulse oximeters that may automatically power off and on, interrupting patient monitoring. Affected units are distributed worldwide.
Masimo Corporation is recalling 65 Masimo Rad-G pulse oximeters due to a potential defect causing automatic power cycling that could result in loss of patient monitoring.
Approximately 21,723 Masimo Rad-G pulse oximeters may randomly power off and on, causing temporary loss of patient monitoring. The FDA classified this as a Class II recall affecting devices distributed worldwide.
Masimo Rad-G pulse oximeters may unexpectedly power off and on, potentially losing monitoring capability. About 4978 units affected worldwide.