Official recall record

Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162

US FDA — Medical Devices · 2025-09-03 · NetherlandsClass II

Issuing authority: US FDA — Medical Devices
Recall initiated by firm: 2025-09-03
Country of alert: Netherlands
Alert level: Class II
Alert type: recall
Barcode (EAN/GTIN): 00884838059030
Brand on record: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

What the authority reported

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.

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

More recalls: US FDA — Medical Devices · Netherlands · all filters

Same barcode in other registries

The same EAN appears in 6 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.

2024-05-16 · US FDA — Medical Devices
Philips Allura Xper FD10 system with an ADN7NT patient table. Model Number: 722010, Software Version Number 8.1.100.
2024-01-02 · US FDA — Medical Devices
Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected
2025-09-03 · US FDA — Medical Devices
Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638,
2022-02-02 · US FDA — Medical Devices
Philips Allura (Model Numbers 722010, 722012, 722026, 722027, 722028, 722029, 722035) and Philips Azurion (Model Numbers
2024-01-02 · US FDA — Medical Devices
Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected

Other recalls from this brand

2026-07-16 · US FDA — Medical Devices
Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222,722223
2026-07-16 · US FDA — Medical Devices
Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235, and 722236, with Soft

All 73 official recall notices naming PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. on this site →

ProductGuru Recalls republishes official safety information with attribution. We are not the issuing authority and this page is not advice. If this product is a medical device or medication, speak to a doctor or pharmacist. Found an error? Report it — corrections are published.