Reported Oct 1, 2025 · Ongoing
Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842,…
Philips Medical Systems Nederland B.v.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Veenpluis 4-6 · Best, N/A · N/A
Is this the product you have?
- Allura Xper FD20 Product Codes
(1)722012(2) 722028(3) 722006
- Associated 510(k) numbers
K102005K130842K130638K133292K141979K161563K162859K033737K041949
- Lot codes and dates
- Product Codes
(1)722012(2) 722028(3) 722006
- UDI-DI
(1) 00884838059054(2) 00884838054202(3) N/A
- Serial numbers
2,114 of 2,114 codes
(1) 9191581111710011673171258551715451715504757935135612501613200614401550173317342201192274122831034135918489502943865190811661113180410014085902508127925094522151172421344815438931455208542312822307179816569901806187125061652
- Product Codes
- Amount recalled
- 2114 units (791 US, 1323 OUS)
This recall covers 13 products
The agency filed one notice per product. You are reading one of them; the other 12 are below.
Where it was sold
- Nationwide
- GA
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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