Philips Allura X-ray system recalled for unauthorized hard drives
Philips Medical Systems Nederland is recalling 257 Allura Centron interventional X-ray systems, model 722400, because they may contain unauthorized hard disk drives. This could potentially cause loss of imaging, loss of motorized movement, or loss of data. The notice does not report any injuries.
From the FDA notice · Read the official notice ↗ · All Philips recalls
What to do
- Contact Philips Medical Systems Nederland B.V. and your facility's biomedical or service team about this recall before making any changes to how the system is used.
- Check the model number (722400) and the UDI on the system against the UDI list in the notice to see whether it is affected.
- The notice does not say how to get a repair or replacement; ask Philips Medical Systems Nederland B.V. for the correction steps.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Philips Allura, Cardio Vascular-Allura Centron. Model Number: 722400. Interventional Fluoroscopic X-Ray System.
- Sold in
- Nationwide
- Made for
- All ages (under 100 years)
This recall covers 3 products — see all of them.
Details
- Units affected
- 257 units
- Illnesses reported
- None reported
- Manufactured in
- Veenpluis 6, Best, Netherlands
- Classification
- Class II
- Recall number
- Z-2893-2026
In the FDA's words
- Description
- Philips Allura, Cardio Vascular-Allura Centron. Model Number: 722400. Interventional Fluoroscopic X-Ray System. Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives. Model Number: 722400. UDI Number: (01)00884838042315(21)282, (01)00884838042315(21)206, (01)00884838042315(21)187, (01)00884838042315(21)486, (01)00884838042315(21)480, (01)00884838042315(21)71, (01)00884838042315(21)322, (01)00884838042315(21)506, (01)00884838042315(21)429, (01)00884838042315(21)413, (01)00884838042315(21)497, (01)00884838042315(21)507, (01)00884838042315(21)502, (01)00884838042315(21)222, (01)00884838042315(21)144, (01)00884838042315(21)510, (01)00884838042315(21)190, (01)00884838042315(21)43, (01)00884838042315(21)439, (01)00884838042315(21)176, (01)00884838042315(21)76, (01)00884838042315(21)364, (01)00884838042315(21)209, (01)00884838042315(21)382, (01)00884838042315(21)178, (01)00884838042315(21)243, (01)00884838042315(21)16, (01)00884838042315(21)110, (01)00884838042315(21)4, (01)00884838042315(21)101, (01)00884838042315(21)131, (01)00884838042315(21)93, (01)00884838042315(21)156, (01)00884838042315(21)347, (01)00884838042315(21)552, (01)00884838042315(21)482, (01)00884838042315(21)414, (01)00884838042315(21)80, (01)00884838042315(21)112, (01)00884838042315(21)42, (01)00884838042315(21)127, (01)00884838042315(21)407, (01)00884838042315(21)33, (01)00884838042315(21)184, (01)00884838042315(21)153, (01)00884838042315(21)189, (01)00884838042315(21)424, (01)00884838042315(21)201, (01)00884838042315(21)245, (01)00884838042315(21)122, (01)00884838042315(21)273, (01)00884838042315(21)228, (01)00884838042315(21)79, (01)00884838042315(21)307, (01)00884838042315(21)476, (01)00884838042315(21)108, (01)00884838042315(21)533, (01)00884838042315(21)250, (01)00884838042315(21)272, (01)00884838042315(21)252, (01)00884838042315(21)30, (01)00884838042315(21)308, (01)00884838042315(21)89, (01)00884838042315(21)525, (01)00884838042315(21)519, (01)00884838042315(21)148, (01)00884838042315(21)100, (01)00884838042315(21)258, (01)00884838042315(21)62, (01)00884838042315(21)22, (01)00884838042315(21)143, (01)00884838042315(21)49, (01)00884838042315(21)31, (01)00884838042315(21)363, (01)00884838042315(21)434, (01)00884838042315(21)70, (01)00884838042315(21)174, (01)00884838042315(21)137, (01)00884838042315(21)257, (01)00884838042315(21)232, (01)00884838042315(21)161, (01)00884838042315(21)471, (01)00884838042315(21)470, (01)00884838042315(21)155, (01)00884838042315(21)150, (01)00884838042315(21)136, (01)00884838042315(21)440, (01)00884838042315(21)545, (01)00884838042315(21)210, (01)00884838042315(21)279, (01)00884838042315(21)6, (01)00884838042315(21)149, (01)00884838042315(21)346, (01)00884838042315(21)317, (01)00884838042315(21)369, (01)00884838042315(21)348, (01)00884838042315(21)380, (01)00884838042315(21)61, (01)00884838042315(21)341, (01)00884838042315(21)438, (01)00884838042315(21)437, (01)00884838042315(21)77, (01)00884838042315(21)96, (01)00884838042315(21)513, (01)00884838042315(21)379, (01)00884838042315(21)355, (01)00884838042315(21)64, (01)00884838042315(21)12, (01)00884838042315(21)485, (01)00884838042315(21)503, (01)00884838042315(21)290, (01)00884838042315(21)168, (01)00884838042315(21)400, (01)00884838042315(21)283, (01)00884838042315(21)512, (01)00884838042315(21)236, (01)00884838042315(21)455, (01)00884838042315(21)173, (01)00884838042315(21)448, (01)00884838042315(21)92, (01)00884838042315(21)251, (01)00884838042315(21)139, (01)00884838042315(21)160, (01)00884838042315(21)109, (01)00884838042315(21)319, (01)00884838042315(21)68, (01)00884838042315(21)56, (01)00884838042315(21)199, (01)00884838042315(21)67, (01)00884838042315(21)233, (01)00884838042315(21)504, (01)00884838042315(21)535, (01)00884838042315(21)116, (01)00884838042315(21)27, (01)00884838042315(21)479, (01)00884838042315(21)423, (01)00884838042315(21)539, (01)00884838042315(21)285, (01)00884838042315(21)419, (01)00884838042315(21)305, (01)00884838042315(21)430, (01)00884838042315(21)449, (01)00884838042315(21)329, (01)00884838042315(21)472, (01)00884838042315(21)356, (01)00884838042315(21)292, (01)00884838042315(21)398, (01)00884838042315(21)230, (01)00884838042315(21)548, (01)00884838042315(21)523, (01)00884838042315(21)299, (01)00884838042315(21)494, (01)00884838042315(21)286, (01)00884838042315(21)488, (01)00884838042315(21)541, (01)00884838042315(21)543, (01)00884838042315(21)427, (01)00884838042315(21)447, (01)00884838042315(21)344, (01)00884838042315(21)542, (01)00884838042315(21)262, (01)00884838042315(21)536, (01)00884838042315(21)469, (01)00884838042315(21)529, (01)00884838042315(21)554, (01)00884838042315(21)555, (01)00884838042315(21)546, (01)00884838042315(21)375, (01)00884838042315(21)534, (01)00884838042315(21)433, (01)00884838042315(21)463, (01)00884838042315(21)443, (01)00884838042315(21)483, (01)00884838042315(21)357, (01)00884838042315(21)374, (01)00884838042315(21)277, (01)
- Hazard
- Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.
3 products in this recall
Philips Allura, Azurion X-ray systems recalled for hard drive risk
Philips is recalling 3 interventional X-ray system lines, sold as Philips Allura (including Allura Xper FD10 and Allura Centron), Philips Azurion, and Allura Centron, with about 8,610 units affected. The systems may contain unauthorized hard disk drives, which could cause loss of imaging, loss of motorized movement, or loss of data. No injuries have been reported.
The agency lists each product separately. Check every one you might have.
- Philips Allura under the following System Descriptions and corresponding model numbers: 1. Allura Xper FD10; Model Numbers: 722003, 722010, 722026. 2. Al…Z-2891-2026 · 5,012 units
- Philips Azurion under the following System Descriptions and corresponding model numbers: 1. Azurion 3 M12; Model Numbers: 722063, 722221. 2. Azurion 3 M1…Z-2892-2026 · 3,341 units
- Philips Allura, Cardio Vascular-Allura Centron. Model Number: 722400. Interventional Fluoroscopic X-Ray System. (this page)Z-2893-2026 · 257 units
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