Official recall record
Allura Xper FD20/15; Model Numbers: 722058; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
- 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)
- 00884838059115
- 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.
Record last checked against the registry on 2026-05-31.
Same barcode in other registries
The same EAN appears in 3 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.
- 2025-09-03 · US FDA — Medical Devices
Allura Xper FD20/15; Product Code: 722058; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K1615 - 2025-01-13 · US FDA — Medical Devices
Allura Xper FD20/15; Catalog numbers: 722058 - 2025-01-13 · US FDA — Medical Devices
AlluraXperFD20/15 System Code: (1) 722058
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 →