FDA (Devices) recall action 97502
The FDA (Devices) publishes a recall like this one as 15 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 15 pages.
The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.
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 is recalling 53 Allura Xper CV20 interventional X-ray systems because the BIOS battery may deplete faster than designed, preventing the system from starting.
Philips is recalling 115 Allura Xper FD20/20 interventional X-ray systems because the BIOS battery may deplete faster than designed, halting start-up.
Philips is recalling eight Allura Xper FD20/15 OR Table systems because the BIOS battery may deplete faster than designed, halting start-up without warning.
Philips is recalling 5,067 Allura Xper FD20 interventional X-ray systems because the BIOS battery may deplete faster than designed, halting start-up with no warning.
Philips is recalling 585 Allura Xper FD10/10 interventional X-ray systems because the BIOS battery may deplete faster than designed, stopping the system from starting.
Philips is recalling 298 Allura Xper FD20 OR Table systems because the BIOS battery may deplete faster than designed, halting start-up.
Philips is recalling four Allura Xper FD20 Biplane OR Table systems because the BIOS battery may deplete faster than designed, stopping the system starting.
Philips is recalling 2,317 Allura Xper FD10 interventional X-ray systems because the BIOS battery may deplete faster than designed, halting start-up with no warning.
Philips is recalling 501 Allura Xper FD20 Biplane interventional X-ray systems because the BIOS battery may deplete faster than designed, halting start-up.
Philips is recalling 313 Cardio Vascular-Allura Centron systems because the BIOS battery may deplete faster than designed, halting start-up with no warning message.
Philips is recalling five Allura Xper FD20/20 OR Table systems because the BIOS battery may deplete faster than designed, halting start-up.
Philips is recalling Allura Xper FD10C interventional X-ray systems because the BIOS battery may deplete faster than designed, halting system start-up with no prior warning.
Philips is recalling 300 Allura Xper FD20/15 interventional X-ray systems because the BIOS battery may deplete faster than designed, halting start-up.
Philips is recalling 87 Allura Xper FD20/10 interventional X-ray systems because the BIOS battery may deplete faster than designed, halting start-up.
Philips is recalling two Allura Xper FD10 OR Table systems because the BIOS battery may deplete faster than designed, stopping the system from starting.