FDA (Devices) recall action 96132
The FDA (Devices) publishes a recall like this one as 20 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 20 pages.
Possibility of the patient falling from the table related to the mattress used on the patient table.
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 Medical Systems is recalling the Allura Xper FD20 Biplane OR Table due to a mattress defect that could cause patients to fall during surgery. 3 units are affected globally.
Philips is recalling Allura Xper FD10 imaging devices because the patient table mattress may not securely hold patients during procedures, creating a fall hazard. The recall affects 2,274 units worldwide, including 459 in the U.S.
Philips is recalling Azurion 5 M20 imaging tables worldwide due to a mattress defect that could cause patients to fall from the table. This FDA Class I recall involves 632 units.
Philips Allura Xper FD20 OR Table units (catalog numbers 722023, 722035) are recalled due to a mattress defect that could cause patients to fall during procedures.
Philips Medical Systems is recalling Azurion 7 B12 examination tables due to a mattress-related patient fall risk. The recall affects 602 total units, including 94 in the US and 508 internationally.
Philips is recalling Azurion 3 M12 patient tables due to possibility of patient falling from the table related to the mattress. The recall affects 263 units distributed in the US and internationally.
Philips is recalling Allura Xper patient table mattresses because a defect could cause patients to fall. The recall involves 302 units distributed globally.
Philips Azurion 7 M12 patient tables are recalled due to a mattress defect that could cause patients to fall. Approximately 1,837 units are affected globally.
Philips is recalling 114 units of the Allura Xper FD20/20 imaging table due to mattress defects that could cause patients to fall. 33 units are in the US; 81 are internationally distributed.
Philips Medical Systems is recalling Azurion 5 M12 imaging tables due to a mattress defect that could allow patients to fall from the table.
Philips recalls Azurion 7 M20 patient tables due to a mattress defect that could cause patients to fall. Approximately 1,480 units in the US and 2,741 units overseas are affected.
Philips is recalling the Allura Xper FD10C patient examination table due to a mattress defect that may allow patients to fall from the table. The device was distributed worldwide.
Philips is recalling Allura Centron patient examination tables due to a mattress defect that poses a fall risk. Eighty units have been distributed internationally.
Philips recalls Allura Xper FD20 fluoroscopy patient tables due to a mattress issue that may cause patients to fall during procedures.
Philips is recalling the Allura Xper FD20/10 imaging system due to a defect in the patient table mattress that could allow patients to fall during procedures. The Class I recall affects 87 units distributed globally, including 22 in the US.
Philips Azurion 7 B20 imaging systems are recalled because the patient table mattress may allow patients to fall. This FDA Class I recall affects 1,314 units distributed worldwide.
Philips Medical is recalling certain Allura Xper FD10/10 fluoroscopy systems because the patient table mattress could cause patients to fall during procedures. The recall affects devices worldwide.
Philips Allura Xper FD20 Biplane x-ray tables are being recalled due to a mattress defect that could cause patients to fall. The recall affects 479 units distributed worldwide.
Philips recalls Azurion 3 M15 imaging tables due to mattress defects that could cause patients to fall from the examination table.
Philips is recalling the Allura CV20 patient table due to a mattress defect that could allow patients to fall. The recall affects 111 units distributed worldwide.