FDA (Devices) recall action 68298
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.
Selenia Full Field Digital Mammography System defective relay switch, if there is a need to use the emergency off switch, the system may not turn off which could result in patient injury
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.
Hologic is recalling three M-IV Mammography Systems because a defective relay switch may prevent the emergency off switch from working, posing a risk of patient injury.
Hologic is recalling 11 Selenia Full Field Digital Mammography Systems because a defective relay switch may prevent the emergency off switch from working, posing a risk of patient injury.