CLASS II ONGOING Device recall · Reported 12 Aug 2026 · FDA Enforcement Report
Philips Allura, Cardio Vascular-Allura Centron recalled
Philips Medical Systems Nederl is recalling Philips Allura, Cardio Vascular-Allura Centron, distributed nationwide in the US. The recall was initiated on 17 Jun 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2893-2026
- FDA event ID
- 99313
- Recalling firm
- Philips Medical Systems Nederl, Best
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 17 Jun 2026
- FDA classified
- 5 Aug 2026
- Reported
- 12 Aug 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 17 Jun 2026 | Recall initiated by company | |
| 5 Aug 2026 | Classified by FDA | +49 days |
| 12 Aug 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.
Product as listed by the FDA
Philips Allura, Cardio Vascular-Allura Centron. Model Number: 722400. Interventional Fluoroscopic X-Ray System.
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.
Which lots are affected?
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)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.
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Philips Medical Systems Nederl
All 200| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Philips Azurion recalled by Philips Medical Systems | Philips Medical Systems Nederl | Potency & Assay | |
| Device | CLASS II | Allura Xper FD recalled by Philips Medical Systems | Philips Medical Systems Nederl | Other | Nationwide |
| Device | CLASS II | Philips Allura Xper with the following recalled | Philips Medical Systems Nederl | Other | |
| Device | CLASS II | Philips MultiDiagnost Eleva with the following recalled | Philips Medical Systems Nederl | Other | |
| Device | CLASS II | Philips Azurion 5M12 recalled by Philips Medical Systems | Philips Medical Systems Nederl | Device Malfunction | Nationwide |
Other Heart & Vascular Devices recalls
All 6,217| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Pipeline Flex Embolization Device with Shield Technology recalled | Micro Therapeutics | Labeling Errors | Nationwide |
| Device | CLASS II | System (RED 62 Reperfusion Catheter) recalled by Penumbra | Penumbra | Device Malfunction | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |