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FDAFDA recall Z-2893-2026 · Aug 12, 2026

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Philips Allura recall

Recall found

Product

Philips Allura, Cardio Vascular-Allura Centron. Model Number: 722400. Interventional Fluoroscopic X-Ray System.

Reason for recall

Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.

What to do

FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.

Recall details

FDA classification
Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Status
Ongoing
Codes, lots and dates
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, 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(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)00884838042315(21)530, (01)00884838042315(21)337, (01)00884838042315(21)549, (01)00884838042315(21)441, (01)00884838042315(21)320, (01)00884838042315(21)445, (01)00884838042315(21)287, (01)00884838042315(21)556, (01)00884838042315(21)446, (01)00884838042315(21)527, (01)00884838042315(21)526, (01)00884838042315(21)521, (01)00884838042315(21)532, (01)00884838042315(21)418, (01)00884838042315(21)51, (01)00884838042315(21)544, (01)00884838042315(21)444, (01)00884838042315(21)511, (01)00884838042315(21)69, (01)00884838042315(21)23, (01)00884838042315(21)20, (01)00884838042315(21)224, (01)00884838042315(21)90, (01)00884838042315(21)267, (01)00884838042315(21)229, (01)00884838042315(21)303, (01)00884838042315(21)334, (01)00884838042315(21)550, (01)00884838042315(21)524, (01)00884838042315(21)540, (01)00884838042315(21)284, (01)00884838042315(21)557, (01)00884838042315(21)316, (01)00884838042315(21)121, (01)00884838042315(21)353, (01)00884838042315(21)553, (01)00884838042315(21)132, (01)00884838042315(21)133, (01)00884838042315(21)315, (01)00884838042315(21)240, (01)00884838042315(21)34, (01)00884838042315(21)102, (01)00884838042315(21)531, (01)00884838042315(21)28, (01)00884838042315(21)297, (01)00884838042315(21)538, (01)00884838042315(21)197, (01)00884838042315(21)19, (01)00884838042315(21)36, (01)00884838042315(21)415, (01)00884838042315(21)300, (01)00884838042315(21)8, (01)00884838042315(21)3, (01)00884838042315(21)151, (01)00884838042315(21)227, (01)00884838042315(21)528, (01)00884838042315(21)259, (01)00884838042315(21)152, (01)00884838042315(21)330, (01)00884838042315(21)264, (01)00884838042315(21)193, (01)00884838042315(21)44, (01)00884838042315(21)462, (01)00884838042315(21)551, (01)00884838042315(21)396, (01)00884838042315(21)460, (01)00884838042315(21)522, (01)00884838042315(21)249, (01)00884838042315(21)244, (01)00884838042315(21)478, (01)00884838042315(21)499, (01)00884838042315(21)515, (01)00884838042315(21)271, (01)00884838042315(21)306, (01)00884838042315(21)435, (01)00884838042315(21)501, (01)00884838042315(21)518, (01)00884838042315(21)140, (01)00884838042315(21)226, (01)00884838042315(21)360, (01)00884838042315(21)370.
Quantity
257 units
Distribution
US Nationwide distribution.
Recalling firm
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., Best
Voluntary or mandated
Voluntary: Firm initiated
Recall started
2026-06-17

Source: openFDA enforcement record Z-2893-2026 · search recall number Z-2893-2026 in FDA's Enforcement Report.

Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.

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