FDA (Devices) recall action 92855
The FDA (Devices) publishes a recall like this one as 3 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 3 pages.
A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation
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.
Philips Allura Xper X-ray imaging systems are being recalled because the foot switch pedal may become stuck in the active position, potentially causing unintended radiation emission. The recall affects 5,432 systems distributed nationwide.
Philips MultiDiagnost-Eleva imaging systems may emit unintended radiation if the foot pedal gets stuck in the active position. The FDA is alerting healthcare facilities to this potential equipment malfunction.
Philips recalls Azurion imaging systems because the foot switch pedal may stick in the active position, causing unintended radiation emission. Facilities should stop using the systems and contact Philips for guidance.