FDA (Devices) recall action 97501

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalled 13 products on 2025-10-01

The FDA (Devices) publishes a recall like this one as 13 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 13 pages.

Products: 13
Announced: 2025-10-01
Critical: 0
Units: 50

Why these products were recalled

Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available.

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.

1–13 of 13

HighFDA (Devices)··2025-10-01
Allura Xper FD20 systems recalled over component deterioration halting motorized movements
Philips Allura Xper FD20 systems are recalled because deterioration of the CMOS battery, hard disk drive and/or power supply may make motorized movements unavailable. 2,114 units are affected.
Product
Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
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HighFDA (Devices)··2025-10-01
Allura Xper FD20/20 OR Table recalled over deteriorating internal system components
Philips Allura Xper FD20/20 OR Table systems are recalled because deterioration of the CMOS battery, hard disk drive and/or power supply may make motorized movements unavailable. 3 units are affected.
Product
Allura Xper FD20/20 OR Table; Product Code: 722039; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
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HighFDA (Devices)··2025-10-01
Allura Xper FD20/20 systems recalled over battery, drive and power supply deterioration
Philips Allura Xper FD20/20 systems are recalled because deterioration of the CMOS battery, hard disk drive and/or power supply may make motorized movements unavailable. 75 units are affected.
Product
Allura Xper FD20/20; Product Code: 722038; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
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ModerateFDA (Devices)··2025-10-01
Allura Xper FD20/15 X-ray System Motorized Movement Component Deterioration
Philips recalls Allura Xper FD20/15 X-ray systems due to potential deterioration of internal components that may disable motorized movements, though manual movements and imaging functionality remain available.
Product
Allura Xper FD20/15; Product Code: 722058; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
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HighFDA (Devices)··2025-10-01
Allura Xper FD10 systems recalled over ageing internal components stopping motorised movement
Philips Allura Xper FD10 systems are recalled because deterioration of the CMOS battery, hard disk drive and/or power supply may make motorized movements unavailable. 1,117 units are affected.
Product
Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
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HighFDA (Devices)··2025-10-01
Allura Xper FD20/10 systems recalled over deterioration disabling motorized movement
Philips Allura Xper FD20/10 systems are recalled because deterioration of the CMOS battery, hard disk drive and/or power supply may make motorized movements unavailable. 45 units are affected.
Product
Allura Xper FD20/10; Product Code: 722029; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
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ModerateFDA (Devices)··2025-10-01
Philips Allura Xper FD10/10 X-Ray System Motorized Movement Failure Recall
Philips Allura Xper FD10/10 X-ray systems may lose motorized movement capability due to deterioration of internal components including the CMOS battery, hard disk drive, or power supply unit. Imaging and manual movements remain functional.
Product
Allura Xper FD10/10 Product Codes: (1)722011, (2) 722027, (3) 722005; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
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HighFDA (Devices)··2025-10-01
Allura Xper FD20/15 OR Table recalled over internal component deterioration
The Philips Allura Xper FD20/15 OR Table is recalled because deterioration of the CMOS battery, hard disk drive and/or power supply may make motorized movements unavailable. One unit is affected.
Product
Allura Xper FD20/15 OR Table; Product Code: 722059; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
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HighFDA (Devices)··2025-10-01
Allura Xper FD20 Biplane OR Table recalled over internal component deterioration
Philips Allura Xper FD20 Biplane OR Table systems are recalled because deterioration of the CMOS battery, hard disk drive and/or power supply may make motorized movements unavailable. 5 units are affected.
Product
Allura Xper FD20 Biplane OR Table Product Codes: (1)722020, (2) 722025; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
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HighFDA (Devices)··2025-10-01
Allura Xper FD20 OR Table recalled over CMOS battery and drive deterioration
Philips Allura Xper FD20 OR Table systems are recalled because deterioration of the CMOS battery, hard disk drive and/or power supply may make motorized movements unavailable. 174 units are affected.
Product
Allura Xper FD20 OR Table Product Codes: (1)722023, (2) 722035, (3) 722015; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
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HighFDA (Devices)··2025-10-01
Allura Xper FD20 Biplane recalled over component deterioration affecting motorized movements
Philips Allura Xper FD20 Biplane systems are recalled because deterioration of the CMOS battery, hard disk drive and/or power supply may make motorized movements unavailable. 268 units are affected.
Product
Allura Xper FD20 Biplane Product Codes: (1)722013, (2) 722008; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
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HighFDA (Devices)··2025-10-01
Allura Xper FD10 OR Table recalled over ageing power supply and drive
Philips Allura Xper FD10 OR Table systems are recalled because deterioration of the CMOS battery, hard disk drive and/or power supply may make motorized movements unavailable. 2 units are affected.
Product
Allura Xper FD10 OR Table Product Codes: (1)722022, (2) 722033; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
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HighFDA (Devices)··2025-10-01
Allura CV20 systems recalled over internal component deterioration disabling motorized movement
Philips Allura CV20 systems are recalled because deterioration of the CMOS battery, hard disk drive and/or power supply may make motorized movements unavailable. 46 units are affected.
Product
Allura CV20; Product Code: 722031; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
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