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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 98801

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 28, 2026
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

3 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 3

Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063), Azurion 3 M15 (722064), Azurion 7 B12 (722067), Azurion 7 B20 (722068), Azurion 7 M12 (722078), Azurion 7 M20 (722079, 722224).

Z-2227-2026
Recall number
Z-2227-2026
Initiated
April 28, 2026
Classification
Class II
Status
Ongoing
Quantity
1651 units (592 US, 1359 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and displays the message Low load fluoroscopy flavor selected: Tube cooler problem . This condition cannot be resolved by restarting the system.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and displays the message Low load fluoroscopy flavor selected: Tube cooler problem . This condition cannot be resolved by restarting the system.

Code information

1. Azurion 3 M12; Model: 722063; UDI: (01)00884838085275(21)64, (01)00884838085275(21)56, (01)00884838085275(21)77, (01)00884838085275(21)82, (01)00884838085275(21)47, (01)00884838085275(21)80, (01)00884838085275(21)102, (01)00884838085275(21)117, (01)00884838085275(21)2, (01)00884838085275(21)99, (01)00884838085275(21)44, (01)00884838085275(21)3, (01)00884838085275(21)62, (01)00884838085275(21)61, (01)00884838085275(21)22, (01)00884838085275(21)29, (01)00884838085275(21)40, (01)00884838085275(21)70, (01)00884838085275(21)30, (01)00884838085275(21)25, (01)00884838085275(21)19, (01)00884838085275(21)18, (01)00884838085275(21)17, (01)00884838085275(21)16, (01)00884838085275(21)14, (01)00884838085275(21)53, (01)00884838085275(21)103, (01)00884838085275(21)101, (01)00884838085275(21)41, (01)00884838085275(21)104, (01)00884838085275(21)93, (01)00884838085275(21)115, (01)00884838085275(21)73, (01)00884838085275(21)128, (01)00884838085275(21)4, (01)00884838085275(21)50, (01)00884838085275(21)72, (01)00884838085275(21)38, (01)00884838085275(21)21, (01)00884838085275(21)78, (01)00884838085275(21)23, (01)00884838085275(21)76, (01)00884838085275(21)63, (01)00884838085275(21)69, (01)00884838085275(21)59, (01)00884838085275(21)51, (01)00884838085275(21)92, (01)00884838085275(21)75, (01)00884838085275(21)94, (01)00884838085275(21)100, (01)00884838085275(21)54, (01)00884838085275(21)46, (01)00884838085275(21)26, (01)00884838085275(21)71, (01)00884838085275(21)106, (01)00884838085275(21)83, (01)00884838085275(21)37, (01)00884838085275(21)36, (01)00884838085275(21)27, (01)00884838085275(21)15, (01)00884838085275(21)85, (01)00884838085275(21)88, (01)00884838085275(21)86, (01)00884838085275(21)90, (01)00884838085275(21)91, (01)00884838085275(21)79, (01)00884838085275(21)81, (01)00884838085275(21)52, (01)00884838085275(21)48, (01)00884838085275(21)55, 2. Azurion 3 M15; Model: 722064; UDI: (01)00884838085282(21)209, (01)00884838085282(21)201, (01)00884838085282(21)64, (01)00884838085282(21)218, (01)00884838085282(21)61, (01)00884838085282(21)161, (01)00884838085282(21)162, (01)00884838085282(21)169, (01)00884838085282(21)131, (01)00884838085282(21)190, (01)00884838085282(21)220, (01)00884838085282(21)173, (01)00884838085282(21)89, (01)00884838085282(21)130, (01)00884838085282(21)60, (01)00884838085282(21)9, (01)00884838085282(21)102, (01)00884838085282(21)137, (01)00884838085282(21)84, (01)00884838085282(21)78, (01)00884838085282(21)49, (01)00884838085282(21)213, (01)00884838085282(21)212, (01)00884838085282(21)193, (01)00884838085282(21)214, (01)00884838085282(21)180, (01)00884838085282(21)185, (01)00884838085282(21)186, (01)00884838085282(21)127, (01)00884838085282(21)106, (01)00884838085282(21)58, (01)00884838085282(21)81, (01)00884838085282(21)200, (01)00884838085282(21)179, (01)00884838085282(21)156, (01)00884838085282(21)230, (01)00884838085282(21)176, (01)00884838085282(21)150, (01)00884838085282(21)149, (01)00884838085282(21)44, (01)00884838085282(21)184, (01)00884838085282(21)6, (01)00884838085282(21)10, (01)00884838085282(21)82, (01)00884838085282(21)35, (01)00884838085282(21)69, (01)00884838085282(21)39, (01)00884838085282(21)66, (01)00884838085282(21)45, (01)00884838085282(21)40, (01)00884838085282(21)125, (01)00884838085282(21)55, (01)00884838085282(21)36, (01)00884838085282(21)94, (01)00884838085282(21)104, (01)00884838085282(21)155, (01)00884838085282(21)132, (01)00884838085282(21)67, (01)00884838085282(21)183, (01)00884838085282(21)70, (01)00884838085282(21)50, (01)00884838085282(21)138, (01)00884838085282(21)151, (01)00884838085282(21)5, (01)00884838085282(21)208, (01)00884838085282(21)57, (01)00884838085282(21)222, (01)00884838085282(21)98, (01)00884838085282(21)79, (01)00884838085282(21)65, (01)00884838085282(21)87, (01)00884838085282(21)109, (01)00884838085282(21)75, (01)00884838085282(21)46, (01)00884838085282(21)101, (01)00884838085282(21)121, (01)00884838085282(21)68, (01)00884838085282(21)91, (01)00884838085282(21)74, (01)00884838085282(21)73, (01)00884838085282(21)124, (01)00884838085282(21)191, (01)00884838085282(21)122, (01)00884838085282(21)119, (01)00884838085282(21)11, (01)00884838085282(21)48, (01)00884838085282(21)147, (01)00884838085282(21)133, (01)00884838085282(21)7, (01)00884838085282(21)235, (01)00884838085282(21)120, (01)00884838085282(21)100, (01)00884838085282(21)51, (01)00884838085282(21)118, (01)00884838085282(21)62, (01)00884838085282(21)123, (01)00884838085282(21)177, (01)00884838085282(21)47, (01)00884838085282(21)272, (01)00884838085282(21)110, (01)00884838085282(21)59, (01)00884838085282(21)167, (01)00884838085282(21)174, (01)00884838085282(21)165, (01)00884838085282(21)41, (01)00884838085282(21)148, (01)00884838085282(21)182, (01)00884838085282(21)112, (01)00884838085282(21)86, (01)00884838085282(21)198, (01)00884838085282(21)206, (01)00884838085282(21)136, (01)00884838085282(21)143, (01)00884838085282(21)226, (01)00884838085282(21)43, (01)00884838085282(21)80, (01)00884838085282(21)12, (01)00884838085282(21)285, (01)00884838085282(21)215, (01)00884838085282(21)164, (01)00884838085282(21)114, (01)00884838085282(21)144, (01)00884838085282(21)227, (01)00884838085282(21)126, (01)00884838085282(21)92, (01)00884838085282(21)284, (01)00884838085282(21)175, (01)00884838085282(21)199, (01)00884838085282(21)188, (01)00884838085282(21)172, (01)00884838085282(21)210, (01)00884838085282(21)134, (01)00884838085282(21)207, (01)00884838085282(21)192, (01)00884838085282(21)116, (01)00884838085282(21)221, (01)00884838085282(21)189, (01)00884838085282(21)117, (01)00884838085282(21)187, (01)00884838085282(21)166, (01)00884838085282(21)96, (01)00884838085282(21)135, (01)00884838085282(21)108, (01)00884838085282(21)37, 3. Azurion 7 B12; Model: 722067; UDI: (01)00884838085350(21)42, (01)00884838085350(21)173, (01)00884838085350(21)109, (01)00884838085350(21)192, (01)00884838085350(21)92, (01)00884838085350(21)103, (01)00884838085350(21)114, (01)00884838085350(21)69, (01)00884838085350(21)41, (01)00884838085350(21)98, (01)00884838085350(21)81, (01)00884838085350(21)123, (01)00884838085350(21)46, (01)00884838085350(21)115, (01)00884838085350(21)150, (01)00884838085350(21)163, (01)00884838085350(21)131, (01)00884838085350(21)71, (01)00884838085350(21)75, (01)00884838085350(21)132, (01)00884838085350(21)147, (01)00884838085350(21)104, (01)00884838085350(21)36, (01)00884838085350(21)70, (01)00884838085350(21)141, (01)00884838085350(21)26, (01)00884838085350(21)148, (01)00884838085350(21)133, (01)00884838085350(21)57, (01)00884838085350(21)190, (01)00884838085350(21)128, (01)00884838085350(21)151, (01)00884838085350(21)68, (01)00884838085350(21)111, (01)00884838085350(21)43, (01)00884838085350(21)33, (01)00884838085350(21)146, (01)00884838085350(21)187, (01)00884838085350(21)74, (01)00884838085350(21)154, (01)00884838085350(21)157, (01)00884838085350(21)29, (01)00884838085350(21)59, (01)00884838085350(21)209, (01)00884838085350(21)95, (01)00884838085350(21)169, (01)00884838085350(21)127, (01)00884838085350(21)30, (01)00884838085350(21)23, (01)00884838085350(21)203, (01)00884838085350(21)138, (01)00884838085350(21)34, (01)00884838085350(21)53, (01)00884838085350(21)113, (01)00884838085350(21)140, (01)00884838085350(21)144, (01)00884838085350(21)60, (01)00884838085350(21)45, (01)00884838085350(21)107, (01)00884838085350(21)112, (01)00884838085350(21)134, (01)00884838085350(21)101, (01)00884838085350(21)100, (01)00884838085350(21)58, (01)00884838085350(21)47, (01)00884838085350(21)176, (01)00884838085350(21)64, (01)00884838085350(21)156, (01)00884838085350(21)52, (01)00884838099265(21)1, (01)00884838085350(21)55, (01)00884838085350(21)54, (01)00884838085350(21)165, (01)00884838085350(21)25, (01)00884838085350(21)35, (01)00884838085350(21)149, (01)00884838085350(21)32, (01)00884838085350(21)224, (01)00884838085350(21)76, (01)00884838085350(21)108, (01)00884838099265(21)17, (01)00884838085350(21)48, (01)00884838085350(21)102, (01)00884838085350(21)105, (01)00884838085350(21)99, (01)00884838085350(21)21, (01)00884838085350(21)159, (01)00884838085350(21)49, (01)00884838085350(21)185, (01)00884838085350(21)51, (01)00884838085350(21)239, (01)00884838085350(21)40, (01)00884838085350(21)94, (01)00884838085350(21)63, (01)00884838085350(21)96, (01)00884838085350(21)129, (01)00884838085350(21)186, (01)00884838085350(21)130, (01)00884838085350(21)161, (01)00884838085350(21)120, (01)00884838085350(21)170, (01)00884838085350(21)171, (01)00884838085350(21)80, (01)00884838085350(21)28, (01)00884838085350(21)145, (01)00884838085350(21)79, (01)00884838085350(21)93, (01)00884838085350(21)137, (01)00884838085350(21)50, (01)00884838085350(21)44, (01)00884838085350(21)38, (01)00884838085350(21)175, (01)00884838085350(21)167, (01)00884838085350(21)78, (01)00884838085350(21)86, (01)00884838085350(21)91, (01)00884838085350(21)37, (01)00884838085350(21)72, (01)00884838085350(21)88, (01)00884838085350(21)27, (01)00884838085350(21)121, (01)00884838085350(21)179, (01)00884838085350(21)183, (01)00884838085350(21)117, (01)00884838085350(21)118, (01)00884838085350(21)85, (01)00884838085350(21)89, (01)00884838085350(21)90, (01)00884838085350(21)119, (01)00884838085350(21)87, (01)00884838085350(21)31, (01)00884838085350(21)110, (01)00884838085350(21)178, (01)00884838085350(21)73, (01)00884838085350(21)39, (01)00884838085350(21)56, (01)00884838085350(21)139, (01)00884838085350(21)61; 4. Azurion 7 B20; Model: 722068; UDI: (01)00884838085367(21)178, (01)00884838085367(21)335, (01)00884838085367(21)147, (01)00884838085367(21)205, (01)00884838085367(21)170, (01)00884838085367(21)95, (01)00884838085367(21)440, (01)00884838085367(21)247, (01)00884838085367(21)225, (01)00884838085367(21)64, (01)00884838085367(21)149, (01)00884838085367(21)42, (01)00884838085367(21)324, (01)00884838085367(21)323, (01)00884838085367(21)320, (01)00884838085367(21)85, (01)00884838085367(21)89, (01)00884838085367(21)109, (01)00884838085367(21)239, (01)00884838085367(21)271, (01)00884838085367(21)104, (01)00884838085367(21)370, (01)00884838085367(21)322, (01)00884838085367(21)136, (01)00884838085367(21)373, (01)00884838085367(21)308, (01)00884838085367(21)354, (01)00884838085367(21)75, (01)00884838085367(21)279, (01)00884838085367(21)400, (01)00884838085367(21)196, (01)00884838085367(21)110, (01)00884838085367(21)78, (01)00884838085367(21)330, (01)00884838085367(21)73, (01)00884838085367(21)288, (01)00884838085367(21)285, (01)00884838085367(21)295, (01)00884838085367(21)329, (01)00884838085367(21)184, (01)00884838085367(21)350, (01)00884838085367(21)304, (01)00884838085367(21)319, (01)00884838085367(21)490, (01)00884838085367(21)243, (01)00884838085367(21)103, (01)00884838085367(21)262, (01)00884838085367(21)261, (01)00884838085367(21)277, (01)00884838085367(21)150, (01)00884838085367(21)172, (01)00884838085367(21)117, (01)00884838085367(21)356, (01)00884838085367(21)130, (01)00884838085367(21)146, (01)00884838085367(21)143, (01)00884838085367(21)84, (01)00884838085367(21)251, (01)00884838085367(21)361, (01)00884838085367(21)76, (01)00884838085367(21)270, (01)00884838085367(21)114, (01)00884838085367(21)232, (01)00884838085367(21)137, (01)00884838085367(21)107, (01)00884838085367(21)282, (01)00884838085367(21)337, (01)00884838085367(21)101, (01)00884838085367(21)213, (01)00884838085367(21)111, (01)00884838085367(21)82, (01)00884838085367(21)113, (01)00884838085367(21)275, (01)00884838085367(21)265, (01)00884838085367(21)459, (01)00884838085367(21)276, (01)00884838085367(21)62, (01)00884838085367(21)302, (01)00884838085367(21)88, (01)00884838085367(21)126, (01)00884838085367(21)211, (01)00884838085367(21)283, (01)00884838085367(21)231, (01)00884838085367(21)207, (01)00884838085367(21)167, (01)00884838085367(21)289, (01)00884838085367(21)233, (01)00884838085367(21)173, (01)00884838085367(21)204, (01)00884838085367(21)77, (01)00884838085367(21)313, (01)00884838085367(21)236, (01)00884838085367(21)237, (01)00884838085367(21)133, (01)00884838085367(21)280, (01)00884838085367(21)307, (01)00884838085367(21)210, (01)00884838085367(21)258, (01)00884838085367(21)328, (01)00884838085367(21)325, (01)00884838085367(21)199, (01)00884838085367(21)53, (01)00884838085367(21)364, (01)00884838085367(21)491, (01)00884838085367(21)246, (01)00884838085367(21)142, (01)00884838085367(21)257, (01)00884838085367(21)140, (01)00884838085367(21)369, (01)00884838085367(21)97, (01)00884838085367(21)87, (01)00884838085367(21)303, (01)00884838085367(21)48, (01)00884838085367(21)44, (01)00884838099272(21)809, (01)00884838085367(21)242, (01)00884838085367(21)238, (01)00884838085367(21)160, (01)00884838085367(21)83, (01)00884838085367(21)68, (01)00884838085367(21)230, (01)00884838085367(21)360, (01)00884838085367(21)93, (01)00884838085367(21)36, (01)00884838099272(21)4, (01)00884838085367(21)372, (01)00884838085367(21)179, (01)00884838085367(21)306, (01)00884838085367(21)182, (01)00884838085367(21)327, (01)00884838085367(21)244, (01)00884838085367(21)382, (01)00884838085367(21)192, (01)00884838085367(21)215, (01)00884838085367(21)399, (01)00884838085367(21)338, (01)00884838085367(21)339, (01)00884838085367(21)316, (01)00884838085367(21)134, (01)00884838085367(21)38, (01)00884838085367(21)158, (01)00884838085367(21)318, (01)00884838085367(21)250, (01)00884838085367(21)118, (01)00884838085367(21)336, (01)00884838085367(21)185, (01)00884838085367(21)206, 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Azurion 7 M12; Model: 722078; UDI: (01)00884838085251(21)302, (01)00884838085251(21)585, (01)00884838085251(21)410, (01)00884838085251(21)523, (01)00884838085251(21)293, (01)00884838085251(21)291, (01)00884838085251(21)536, (01)00884838085251(21)537, (01)00884838085251(21)613, (01)00884838085251(21)598, (01)00884838085251(21)224, (01)00884838085251(21)249, (01)00884838085251(21)546, (01)00884838085251(21)478, (01)00884838085251(21)479, (01)00884838085251(21)513, (01)00884838085251(21)278, (01)00884838085251(21)438, (01)00884838085251(21)437, (01)00884838085251(21)456, (01)00884838085251(21)566, (01)00884838085251(21)488, (01)00884838085251(21)550, (01)00884838085251(21)571, (01)00884838085251(21)545, (01)00884838085251(21)544, (01)00884838085251(21)465, (01)00884838085251(21)376, (01)00884838085251(21)31, (01)00884838085251(21)165, (01)00884838085251(21)445, (01)00884838085251(21)539, (01)00884838085251(21)654, (01)00884838085251(21)656, (01)00884838085251(21)658, 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(01)00884838085251(21)10, (01)00884838085251(21)123, (01)00884838085251(21)319, (01)00884838085251(21)686, (01)00884838085251(21)397, (01)00884838085251(21)128, (01)00884838085251(21)127, (01)00884838085251(21)253, (01)00884838085251(21)300, (01)00884838085251(21)321, (01)00884838085251(21)35, (01)00884838085251(21)332, (01)00884838085251(21)341, (01)00884838085251(21)316, (01)00884838085251(21)314, (01)00884838085251(21)496, (01)00884838085251(21)641, (01)00884838085251(21)30, (01)00884838085251(21)331, (01)00884838085251(21)652, (01)00884838085251(21)349, (01)00884838085251(21)236, (01)00884838085251(21)501, (01)00884838085251(21)682, (01)00884838085251(21)323, (01)00884838085251(21)315, (01)00884838085251(21)680, (01)00884838085251(21)311, (01)00884838085251(21)312, (01)00884838085251(21)282, (01)00884838085251(21)283, (01)00884838085251(21)602, (01)00884838085251(21)203, (01)00884838085251(21)202, (01)00884838085251(21)40, (01)00884838085251(21)295, (01)00884838085251(21)368, (01)00884838085251(21)369, (01)00884838085251(21)615, (01)00884838085251(21)618, (01)00884838085251(21)310, (01)00884838085251(21)199, (01)00884838085251(21)455, (01)00884838085251(21)668, (01)00884838085251(21)352, (01)00884838085251(21)193, (01)00884838085251(21)667, (01)00884838085251(21)567, (01)00884838085251(21)183, (01)00884838085251(21)692, (01)00884838085251(21)32, (01)00884838085251(21)241, (01)00884838085251(21)505, (01)00884838085251(21)407, (01)00884838085251(21)408, (01)00884838085251(21)138, (01)00884838085251(21)752, (01)00884838085251(21)157, (01)00884838085251(21)463, (01)00884838085251(21)461, (01)00884838085251(21)423, (01)00884838085251(21)554, (01)00884838085251(21)252, (01)00884838085251(21)426, (01)00884838085251(21)650, (01)00884838085251(21)169, (01)00884838085251(21)442, (01)00884838085251(21)351, (01)00884838085251(21)209, (01)00884838085251(21)207, (01)00884838085251(21)208, (01)00884838085251(21)211, (01)00884838085251(21)210, (01)00884838085251(21)623, (01)00884838085251(21)622, (01)00884838085251(21)629, (01)00884838085251(21)129, (01)00884838085251(21)529, (01)00884838085251(21)144, (01)00884838085251(21)400, (01)00884838085251(21)401, (01)00884838085251(21)411, (01)00884838085251(21)259, (01)00884838085251(21)457, (01)00884838085251(21)597, (01)00884838085251(21)418, (01)00884838085251(21)173, (01)00884838085251(21)637, (01)00884838085251(21)601, (01)00884838085251(21)37, (01)00884838085251(21)227, (01)00884838085251(21)716, (01)00884838085251(21)717, (01)00884838085251(21)620, (01)00884838085251(21)663, (01)00884838085251(21)736, (01)00884838085251(21)272, (01)00884838085251(21)712, (01)00884838085251(21)233, (01)00884838085251(21)638, (01)00884838085251(21)318, (01)00884838085251(21)593, (01)00884838085251(21)624, (01)00884838085251(21)21, (01)00884838085251(21)267, (01)00884838085251(21)268, (01)00884838085251(21)487, (01)00884838085251(21)421, (01)00884838085251(21)760, (01)00884838085251(21)542, (01)00884838085251(21)614, (01)00884838085251(21)148, (01)00884838085251(21)458, (01)00884838085251(21)596, (01)00884838085251(21)377, (01)00884838085251(21)281, (01)00884838085251(21)659, (01)00884838085251(21)528, (01)00884838085251(21)44, (01)00884838085251(21)43, (01)00884838085251(21)42, (01)00884838085251(21)45, (01)00884838085251(21)41, (01)00884838085251(21)219, (01)00884838085251(21)29, (01)00884838085251(21)28, (01)00884838085251(21)217, (01)00884838085251(21)103, (01)00884838085251(21)430, (01)00884838085251(21)342, (01)00884838085251(21)126, (01)00884838085251(21)184, (01)00884838085251(21)547, (01)00884838085251(21)586, (01)00884838085251(21)159, (01)00884838085251(21)363, (01)00884838085251(21)642, (01)00884838085251(21)472, (01)00884838085251(21)39, (01)00884838085251(21)172, (01)00884838085251(21)33, (01)00884838085251(21)643, (01)00884838085251(21)581, (01)00884838085251(21)552, (01)00884838085251(21)525, (01)00884838085251(21)510, (01)00884838085251(21)433, (01)00884838085251(21)432, (01)00884838085251(21)636, (01)00884838085251(21)447, (01)00884838085251(21)333, (01)00884838085251(21)358, (01)00884838085251(21)540, (01)00884838085251(21)619, (01)00884838085251(21)492, (01)00884838085251(21)527, (01)00884838085251(21)600, (01)00884838085251(21)434, (01)00884838085251(21)124, (01)00884838085251(21)122, (01)00884838085251(21)146, (01)00884838085251(21)201, (01)00884838085251(21)509, (01)00884838085251(21)495, (01)00884838085251(21)515, (01)00884838085251(21)353, (01)00884838085251(21)303, (01)00884838085251(21)304, (01)00884838085251(21)286, (01)00884838085251(21)548, (01)00884838085251(21)518, (01)00884838085251(21)486, (01)00884838085251(21)474, (01)00884838085251(21)180, (01)00884838085251(21)244, (01)00884838085251(21)243, (01)00884838085251(21)335, (01)00884838085251(21)549, (01)00884838085251(21)46, (01)00884838085251(21)616, (01)00884838085251(21)533, (01)00884838085251(21)182, (01)00884838085251(21)696, (01)00884838085251(21)345, (01)00884838085251(21)575, (01)00884838085251(21)871, (01)00884838085251(21)18, (01)00884838085251(21)551, (01)00884838085251(21)543, (01)00884838085251(21)516, (01)00884838085251(21)12, (01)00884838085251(21)155, (01)00884838085251(21)446, (01)00884838085251(21)685, (01)00884838085251(21)715, (01)00884838085251(21)225, (01)00884838085251(21)582, (01)00884838085251(21)19, (01)00884838085251(21)435, (01)00884838085251(21)16, (01)00884838085251(21)11, (01)00884838085251(21)167, (01)00884838085251(21)664, (01)00884838085251(21)508, (01)00884838085251(21)530; 6. Azurion 7 M12; Model: 722223; UDI: (01)00884838099241(21)61, (01)00884838099241(21)6, (01)00884838099241(21)12, (01)00884838099241(21)2; 7. Azurion 7 M20; Model: 722079; UDI: (01)00884838085268(21)1023, (01)00884838085268(21)645, (01)00884838085268(21)646, (01)00884838085268(21)1013, (01)00884838085268(21)460, (01)00884838085268(21)43, (01)00884838085268(21)35, (01)00884838085268(21)890, (01)00884838085268(21)1137, (01)00884838085268(21)1048, (01)00884838085268(21)401, (01)00884838085268(21)1010, (01)00884838085268(21)1054, (01)00884838085268(21)536, (01)00884838085268(21)534, (01)00884838085268(21)535, (01)00884838085268(21)266, (01)00884838085268(21)818, (01)00884838085268(21)412, (01)00884838085268(21)617, (01)00884838085268(21)246, (01)00884838085268(21)488, (01)00884838085268(21)53, (01)00884838085268(21)57, (01)00884838085268(21)905, (01)00884838085268(21)55, (01)00884838085268(21)992, (01)00884838085268(21)691, (01)00884838085268(21)809, (01)00884838085268(21)848, (01)00884838085268(21)1033, (01)00884838085268(21)891, (01)00884838085268(21)836, (01)00884838085268(21)1155, (01)00884838085268(21)466, (01)00884838085268(21)1157, (01)00884838085268(21)263, (01)00884838085268(21)420, (01)00884838085268(21)673, (01)00884838085268(21)298, (01)00884838085268(21)297, (01)00884838085268(21)299, (01)00884838085268(21)564, (01)00884838085268(21)838, (01)00884838085268(21)1117, (01)00884838085268(21)1032, (01)00884838085268(21)820, (01)00884838085268(21)987, (01)00884838085268(21)47, (01)00884838085268(21)881, (01)00884838085268(21)774, (01)00884838085268(21)856, (01)00884838085268(21)922, (01)00884838085268(21)58, (01)00884838085268(21)471, (01)00884838085268(21)955, (01)00884838085268(21)755, (01)00884838085268(21)633, (01)00884838085268(21)296, (01)00884838085268(21)884, (01)00884838085268(21)574, (01)00884838085268(21)991, (01)00884838085268(21)842, (01)00884838085268(21)753, (01)00884838085268(21)840, (01)00884838085268(21)790, (01)00884838085268(21)481, (01)00884838085268(21)407, (01)00884838085268(21)408, (01)00884838085268(21)877, (01)00884838085268(21)590, (01)00884838085268(21)710, (01)00884838085268(21)713, (01)00884838085268(21)711, (01)00884838085268(21)709, (01)00884838085268(21)716, (01)00884838085268(21)1216, (01)00884838085268(21)483, (01)00884838085268(21)1098, (01)00884838085268(21)241, (01)00884838085268(21)1108, (01)00884838085268(21)863, (01)00884838085268(21)350, (01)0088483808

Distribution pattern

Domestic: Nationwide; International: Canada, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Ethiopia, Finland, France, French Polynesia, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Republic of, Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Malaysia, Maldives, Malta, Martinique, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Viet Nam, Yemen;

device · product 2 of 3

Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/20 (722038), Allura Xper FD20/20 OR Table (722039), Cardio Vascular-Allura (722400);

Z-2228-2026
Recall number
Z-2228-2026
Initiated
April 28, 2026
Classification
Class II
Status
Ongoing
Quantity
3314 units (816 US, 2498 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and displays the message Low load fluoroscopy flavor selected: Tube cooler problem . This condition cannot be resolved by restarting the system.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and displays the message Low load fluoroscopy flavor selected: Tube cooler problem . This condition cannot be resolved by restarting the system.

Code information

Code Information: Allura: 1. Allura Xper FD10C; Model: 722001; UDI-DI: N/A; Serial Numbers: 170, 242, 267, 142, 206, 316, 9, 306, 103, 33, 220; 2. Allura Xper FD10F; Model: 722002; UDI-DI: N/A; Serial Numbers: 0, 81, 47; 3. Allura Xper FD10; Model: 722003; UDI-DI: N/A; Serial Numbers: 208, 392, 109, 45, 1953, 1471, 1551, 485, 152, 928, 501, 90, 1435, 81, 939, 160, 472, 1349, 439, 1958, 1525, 72, 1187, 912, 368, 328A, 37, 1286, 1223, 487, 1061, 833, 688, 317, 157, 639, 375, 420, 225, 1338, 614, 214, 230, 736, 64, 1090, 1094, 1932, 1531, 421, 984, 373, 313, 918, 602, 374, 750, 1934, 1751, 1661, 961, 791, 454, 868, 416, 1329, 241; 4. Allura Xper FD10; Model: 722010; UDI: (01)00884838059030(21)921, (01)00884838059030(21)1440, (01)00884838059030(21)1328, (01)00884838059030(21)1292, (01)00884838059030(21)1428, (01)00884838059030(21)1396, (01)00884838059030(21)298, (01)00884838059030(21)1432, (01)00884838059030(21)1425, (01)00884838059030(21)1398, (01)00884838059030(21)1397, (01)00884838059030(21)1391, (01)00884838059030(21)1395, (01)00884838059030(21)314, (01)00884838059030(21)1297, (01)00884838059030(21)946, (01)00884838059030(21)1424, (01)00884838059030(21)1244, (01)00884838059030(21)1122, (01)00884838059030(21)1198, (01)00884838059030(21)1421, (01)00884838059030(21)1423, (01)00884838059030(21)1438, (01)00884838059030(21)697, (01)00884838059030(21)1192, (01)00884838059030(21)1326, (01)00884838059030(21)402, (01)00884838059030(21)1148, (01)00884838059030(21)1439, (01)00884838059030(21)1431, (01)00884838059030(21)1404, (01)00884838059030(21)1140, (01)00884838059030(21)1429, (01)00884838059030(21)1430, (01)00884838059030(21)1403, (01)00884838059030(21)1393, (01)00884838059030(21)1402, (01)00884838059030(21)406, (01)00884838059030(21)71, (01)00884838059030(21)1434, (01)00884838059030(21)1392, (01)00884838059030(21)1379, (01)00884838059030(21)1401, (01)00884838059030(21)1197, (01)00884838059030(21)1435, (01)00884838059030(21)1346, (01)00884838059030(21)232, (01)00884838059030(21)231, (01)00884838059030(21)248, (01)00884838059030(21)1137, (01)00884838059030(21)1446, (01)00884838059030(21)1422, (01)00884838059030(21)1433, (01)00884838059030(21)1131, (01)00884838059030(21)1218; 5. Allura Xper FD10; Model: 722026; UDI: (01)00884838054189(21)683, (01)00884838054189(21)1052, (01)00884838054189(21)1051, (01)00884838054189(21)786, (01)00884838054189(21)654, (01)00884838054189(21)1132, (01)00884838054189(21)1100, (01)00884838054189(21)770, (01)00884838054189(21)1338, (01)00884838054189(21)1068, (01)00884838054189(21)1072, (01)00884838054189(21)796, (01)00884838054189(21)1248, (01)00884838054189(21)1129, (01)00884838054189(21)781, (01)00884838054189(21)634, (01)00884838054189(21)908, (01)00884838054189(21)969, (01)00884838054189(21)1246, (01)00884838054189(21)877, (01)00884838054189(21)843, (01)00884838054189(21)1231, (01)00884838054189(21)1038, (01)00884838054189(21)1287, (01)00884838054189(21)878, (01)00884838054189(21)558, (01)00884838054189(21)633, (01)00884838054189(21)1050, (01)00884838054189(21)1000, (01)00884838054189(21)909, (01)00884838054189(21)841, (01)00884838054189(21)713, (01)00884838054189(21)731, (01)00884838054189(21)646, (01)00884838054189(21)728, 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(01)00884838054189(21)1004, (01)00884838054189(21)886, (01)00884838054189(21)887, (01)00884838054189(21)1102, (01)00884838054189(21)1002, (01)00884838054189(21)308, (01)00884838054189(21)1058, (01)00884838054189(21)896, (01)00884838054189(21)710, (01)00884838054189(21)1151, (01)00884838054189(21)706, (01)00884838054189(21)443, (01)00884838054189(21)442, (01)00884838054189(21)547, (01)00884838054189(21)870, (01)00884838054189(21)1365, (01)00884838054189(21)889, (01)00884838054189(21)412, (01)00884838054189(21)862, (01)00884838054189(21)1369, (01)00884838054189(21)1090, (01)00884838054189(21)1273, (01)00884838054189(21)788, (01)00884838054189(21)1345, (01)00884838054189(21)1344, (01)00884838054189(21)827, (01)00884838054189(21)1030, (01)00884838054189(21)1178, (01)00884838054189(21)1131, (01)00884838054189(21)675, (01)00884838054189(21)1322, (01)00884838054189(21)623, (01)00884838054189(21)853, (01)00884838054189(21)1172, (01)00884838054189(21)892, (01)00884838054189(21)588, (01)00884838054189(21)1257, (01)00884838054189(21)743, (01)00884838054189(21)1162, (01)00884838054189(21)1323, (01)00884838054189(21)1325, (01)00884838054189(21)876, (01)00884838054189(21)655, (01)00884838054189(21)974, (01)00884838054189(21)793, (01)00884838054189(21)907, (01)00884838054189(21)1251, (01)00884838054189(21)669; 6. Allura Xper FD10/10; Model: 722005; UDI-DI: N/A: Serial Numbers: 51, 22, 259, 196, 530, 435, 233, 309, 89, 29, 399, 480, 6, 41, 71, 124, 458, 54, 55, 528, 80, 556, 74, 203, 60, 125, 426, 123, 64, 299; 7. Allura Xper FD10/10; Model: 722011; UDI: (01)00884838059047(21)49, (01)00884838059047(21)196, (01)00884838059047(21)157, (01)00884838059047(21)82, (01)00884838059047(21)83, (01)00884838059047(21)275, (01)00884838059047(21)101, (01)00884838059047(21)347, (01)00884838059047(21)198, (01)00884838059047(21)94, (01)00884838059047(21)176, (01)00884838059047(21)329, (01)00884838059047(21)337; 8. Allura Xper FD10/10; Model: 722027; UDI: (01)00884838054196(21)351, (01)00884838054196(21)332, (01)00884838054196(21)71, (01)00884838054196(21)240, (01)00884838054196(21)241, (01)00884838054196(21)298, (01)00884838054196(21)175, (01)00884838054196(21)280, (01)00884838054196(21)222, (01)00884838054196(21)183, (01)00884838054196(21)202, (01)00884838054196(21)164, (01)00884838054196(21)335, (01)00884838054196(21)288, (01)00884838054196(21)342, (01)00884838054196(21)306, (01)00884838054196(21)307, (01)00884838054196(21)265, (01)00884838054196(21)169, (01)00884838054196(21)203, (01)00884838054196(21)234, (01)00884838054196(21)267, (01)00884838054196(21)209, (01)00884838054196(21)284, (01)00884838054196(21)263, (01)00884838054196(21)174, (01)00884838054196(21)305, (01)00884838054196(21)246, (01)00884838054196(21)255, (01)00884838054196(21)178, (01)00884838054196(21)266, (01)00884838054196(21)187, (01)00884838054196(21)321, (01)00884838054196(21)328, (01)00884838054196(21)282, (01)00884838054196(21)184, (01)00884838054196(21)337, (01)00884838054196(21)357, (01)00884838054196(21)213, (01)00884838054196(21)293, (01)00884838054196(21)292, (01)00884838054196(21)346, (01)00884838054196(21)211, (01)00884838054196(21)144, (01)00884838054196(21)238, (01)00884838054196(21)247, (01)00884838054196(21)347, (01)00884838054196(21)188, (01)00884838054196(21)196, (01)00884838054196(21)339, (01)00884838054196(21)343, (01)00884838054196(21)256, (01)00884838054196(21)338, (01)00884838054196(21)334, (01)00884838054196(21)294, (01)00884838054196(21)345, (01)00884838054196(21)172, (01)00884838054196(21)323, (01)00884838054196(21)324, (01)00884838054196(21)189, (01)00884838054196(21)212, (01)00884838054196(21)268, (01)00884838054196(21)356, (01)00884838054196(21)244, (01)00884838054196(21)254, (01)00884838054196(21)362, (01)00884838054196(21)271, (01)00884838054196(21)186, (01)00884838054196(21)259, (01)00884838054196(21)236, (01)00884838054196(21)201, (01)00884838054196(21)275, (01)00884838054196(21)277, (01)00884838054196(21)349, (01)00884838054196(21)350, (01)00884838054196(21)348, (01)00884838054196(21)273, (01)00884838054196(21)249, (01)00884838054196(21)149, (01)00884838054196(21)148, (01)00884838054196(21)316, (01)00884838054196(21)274, (01)00884838054196(21)205, (01)00884838054196(21)270, (01)00884838054196(21)223, (01)00884838054196(21)181, (01)00884838054196(21)221, (01)00884838054196(21)245, (01)00884838054196(21)352, (01)00884838054196(21)358, (01)00884838054196(21)361, (01)00884838054196(21)228, (01)00884838054196(21)142, (01)00884838054196(21)214, (01)00884838054196(21)299, (01)00884838054196(21)114, (01)00884838054196(21)204, (01)00884838054196(21)225, (01)00884838054196(21)297, (01)00884838054196(21)182, (01)00884838054196(21)177, (01)00884838054196(21)300, (01)00884838054196(21)130, (01)00884838054196(21)210, (01)00884838054196(21)261, (01)00884838054196(21)260, (01)00884838054196(21)322, (01)00884838054196(21)360, (01)00884838054196(21)310, (01)00884838054196(21)291, (01)00884838054196(21)180, (01)00884838054196(21)287, (01)00884838054196(21)264, (01)00884838054196(21)272, (01)00884838054196(21)207, (01)00884838054196(21)239, (01)00884838054196(21)308, (01)00884838054196(21)243, (01)00884838054196(21)242, (01)00884838054196(21)218, (01)00884838054196(21)197, (01)00884838054196(21)235, (01)00884838054196(21)278, (01)00884838054196(21)250, (01)00884838054196(21)227, (01)00884838054196(21)233, (01)00884838054196(21)329, (01)00884838054196(21)296, (01)00884838054196(21)193, (01)00884838054196(21)219, (01)00884838054196(21)276, (01)00884838054196(21)326, (01)00884838054196(21)312, (01)00884838054196(21)304, (01)00884838054196(21)311, (01)00884838054196(21)199, (01)00884838054196(21)192, (01)00884838054196(21)289, (01)00884838054196(21)217, (01)00884838054196(21)355, (01)00884838054196(21)232, (01)00884838054196(21)315, (01)00884838054196(21)309, (01)00884838054196(21)171, (01)00884838054196(21)191, (01)00884838054196(21)269, (01)00884838054196(21)206, (01)00884838054196(21)330, (01)00884838054196(21)195, (01)00884838054196(21)215, (01)00884838054196(21)220, (01)00884838054196(21)198, (01)00884838054196(21)208, (01)00884838054196(21)286; 9. Allura Xper FD20; Model: 722006; UDI-DI: N/A; Serial Numbers: 2051, 1936, 518, 326, 66, 2587, 332, 249, 2274, 1496, 2183, 579, 1044, 2336, 443, 1913, 1259, 79, 939, 283, 405, 2161, 2068, 560, 1747, 1601, 479, 970, 1586, 878, 2537, 658, 384, 1469, 588, 328, 235, 381, 1536, 2504, 103, 826, 962, 169, 1197, 223, 595, 934, 1364, 972, 2567, 2042, 2380, 828, 528, 288, 1889, 1578, 1000, 942, 104, 2257, 1977, 1594, 118, 2003, 226, 1978, 333, 52, 53, 1242, 203, 521, 2427, 191, 1611, 1287, 250, 1582, 301, 1615, 1007, 01H041985, 2301, 1276, 234, 655, 914, 1302, 767, 781, 1038, 1306, 346, 8, 1524, 598, 639, 434, 687, 1580, 157, 491, 393, 621, 63, 2465, 2206, 585, 2487, 608, 1793, 884, 955, 1529, 1678, 1106, 946, 1650, 408, 1893, 380, 873, 102, 1232, 430, 1990, 1450, 957, 507, 1192, 136, 940, 274, 581, 2592, 2379, 890, 602, 280, 2493, 640, 2, 511; 10. Allura Xper FD20; Model: 722012; UDI: (01)00884838059054(21)2942, (01)00884838059054(21)2265, (01)00884838059054(21)2735, (01)00884838059054(21)2707, (01)00884838059054(21)135, (01)00884838059054(21)2740, (01)00884838059054(21)2843, (01)00884838059054(21)2835, (01)00884838059054(21)760, (01)00884838059054(21)735, (01)00884838059054(21)174, (01)00884838059054(21)2855, (01)00884838059054(21)2856, (01)00884838059054(21)2712, (01)00884838059054(21)606, (01)00884838059054(21)2721, (01)00884838059054(21)2085, (01)00884838059054(21)695, (01)00884838059054(21)2202, (01)00884838059054(21)2828, (01)00884838059054(21)601, (01)00884838059054(21)1207, (01)00884838059054(21)2898, (01)00884838059054(21)334, (01)00884838059054(21)1656, (01)00884838059054(21)483, (01)00884838059054(21)2305, (01)00884838059054(21)2896, (01)00884838059054(21)2726, (01)00884838059054(21)2722, (01)00884838059054(21)451, (01)00884838059054(21)2883, (01)00884838059054(21)2755, (01)00884838059054(21)2741, (01)00884838059054(21)1301, (01)00884838059054(21)2736, (01)00884838059054(21)782, (01)00884838059054(21)2890, (01)00884838059054(21)2829, (01)00884838059054(21)1675, (01)00884838059054(21)412, (01)00884838059054(21)320, (01)00884838059054(21)1224, (01)00884838059054(21)453, (01)00884838059054(21)1964, (01)00884838059054(21)325, (01)00884838059054(21)2742, (01)00884838059054(21)2889, (01)00884838059054(21)2713, (01)00884838059054(21)2899, (01)00884838059054(21)1272, (01)00884838059054(21)2857, (01)00884838059054(21)2886, (01)00884838059054(21)100, (01)00884838059054(21)2875, (01)00884838059054(21)2888, (01)00884838059054(21)71, (01)00884838059054(21)1807, (01)00884838059054(21)418, (01)00884838059054(21)1329, (01)00884838059054(21)2873, (01)00884838059054(21)1075, (01)00884838059054(21)2842, (01)00884838059054(21)2841, (01)00884838059054(21)2849, (01)00884838059054(21)2840, (01)00884838059054(21)2901, (01)00884838059054(21)1226, (01)00884838059054(21)2774, (01)00884838059054(21)1441, (01)00884838059054(21)2723, (01)00884838059054(21)2900, (01)00884838059054(21)316, (01)00884838059054(21)2892, (01)00884838059054(21)527, (01)00884838059054(21)2876, (01)00884838059054(21)2881, (01)00884838059054(21)525, (01)00884838059054(21)1806, (01)00884838059054(21)2844, (01)00884838059054(21)1712, (01)00884838059054(21)2760, (01)00884838059054(21)2868, (01)00884838059054(21)2869, (01)00884838059054(21)718, (01)00884838059054(21)1282, (01)00884838059054(21)1946, (01)00884838059054(21)2912, (01)00884838059054(21)1622, (01)00884838059054(21)2874, (01)00884838059054(21)351, (01)00884838059054(21)1655, (01)00884838059054(21)2282, (01)00884838059054(21)2891, (01)00884838059054(21)2764, (01)00884838059054(21)2880, (01)00884838059054(21)1171, (01)00884838059054(21)1921, (01)00884838059054(21)2838, (01)00884838059054(21)2887, (01)00884838059054(21)2567, (01)00884838059054(21)2703, (01)00884838059054(21)2759, (01)00884838059054(21)2945, (01)00884838059054(21)1747, (01)00884838059054(21)2879, (01)00884838059054(21)2335, (01)00884838059054(21)2913, (01)00884838059054(21)537, (01)00884838059054(21)2897, (01)00884838059054(21)288, (01)00884838059054(21)191, (01)00884838059054(21)2917, (01)00884838059054(21)2915, (01)00884838059054(21)2850, (01)00884838059054(21)2825, (01)00884838059054(21)2579, (01)00884838059054(21)2916, (01)00884838059054(21)2667, (01)00884838059054(21)2681, (01)00884838059054(21)2784, (01)00884838059054(21)2747, (01)00884838059054(21)2914, (01)00884838059054(21)1911, (01)00884838059054(21)2831, (01)00884838059054(21)2749, (01)00884838059054(21)2801, (01)00884838059054(21)2771, (01)00884838059054(21)2724, (01)00884838059054(21)2877, (01)00884838059054(21)2788, (01)00884838059054(21)2702, (01)00884838059054(21)465, (01)00884838059054(21)309, (01)00884838059054(21)2827, (01)00884838059054(21)2806, (01)00884838059054(21)1628, (01)00884838059054(21)2934, (01)00884838059054(21)2763, (01)00884838059054(21)2810, (01)00884838059054(21)2581, (01)00884838059054(21)2623, (01)00884838059054(21)2647, (01)00884838059054(21)2854, (01)00884838059054(21)2548, (01)00884838059054(21)2745, (01)00884838059054(21)2812, (01)00884838059054(21)2676, (01)00884838059054(21)2599, (01)00884838059054(21)2789, (01)00884838059054(21)2818, (01)00884838059054(21)2678, (01)00884838059054(21)2701, (01)00884838059054(21)2756, (01)00884838059054(21)1256, (01)00884838059054(21)2830, (01)00884838059054(21)982, (01)00884838059054(21)2565, (01)00884838059054(21)2752, (01)00884838059054(21)2811, (01)00884838059054(21)2852, (01)00884838059054(21)2671, (01)00884838059054(21)2649, (01)00884838059054(21)2698, (01)00884838059054(21)2661, (01)00884838059054(21)2690, (01)00884838059054(21)2775, (01)00884838059054(21)2773, (01)00884838059054(21)2834, (01)00884838059054(21)2720, (01)00884838059054(21)2626, (01)00884838059054(21)2823, (01)00884838059054(21)374, (01)00884838059054(21)2782, (01)00884838059054(21)2766, (01)00884838059054(21)2776, (01)00884838059054(21)2826, (01)00884838059054(21)2738, (01)00884838059054(21)2851, (01)00884838059054(21)2777, (01)00884838059054(21)2739, (01)00884838059054(21)2847, (01)00884838059054(21)2832, (01)00884838059054(21)2725, (01)00884838059054(21)2650, (01)00884838059054(21)2813, (01)00884838059054(21)998, (01)00884838059054(21)2744, (01)00884838059054(21)2797, (01)00884838059054(21)2229, (01)00884838059054(21)2228, (01)00884838059054(21)2781, (01)00884838059054(21)2853, (01)00884838059054(21)2716, (01)00884838059054(21)2808, (01)00884838059054(21)2837, (01)00884838059054(21)2768, (01)00884838059054(21)2673, (01)00884838059054(21)2674, (01)00884838059054(21)2803, (01)00884838059054(21)2732, (01)00884838059054(21)2798, (01)00884838059054(21)2786, (01)00884838059054(21)2778, (01)00884838059054(21)2559, (01)00884838059054(21)2746, (01)00884838059054(21)2770, (01)00884838059054(21)2691, (01)00884838059054(21)2762, (01)00884838059054(21)2729, (01)00884838059054(21)2750, (01)00884838059054(21)2804, (01)00884838059054(21)2751, (01)00884838059054(21)2640, (01)00884838059054(21)2730, (01)00884838059054(21)2562, (01)00884838059054(21)2795, (01)00884838059054(21)2718, (01)00884838059054(21)2682, (01)00884838059054(21)2574, (01)00884838059054(21)2779, (01)00884838059054(21)2711, (01)00884838059054(21)2758, (01)00884838059054(21)2836, (01)00884838059054(21)2733, (01)00884838059054(21)2824, (01)00884838059054(21)2715, (01)00884838059054(21)2704, (01)00884838059054(21)2734, (01)00884838059054(21)2793, (01)00884838059054(21)2792, (01)00884838059054(21)2566, (01)00884838059054(21)2757, (01)00884838059054(21)2765, (01)00884838059054(21)2785, (01)00884838059054(21)2767, (01)00884838059054(21)2794, (01)00884838059054(21)240, (01)00884838059054(21)2719, (01)00884838059054(21)2708, (01)00884838059054(21)2882, (01)00884838059054(21)2169, (01)00884838059054(21)2802, (01)00884838059054(21)2761, (01)00884838059054(21)2799, (01)00884838059054(21)2652, (01)00884838059054(21)2743, (01)00884838059054(21)2790, (01)00884838059054(21)2748, (01)00884838059054(21)2911, (01)00884838059054(21)2714, (01)00884838059054(21)2688, (01)00884838059054(21)2780, (01)00884838059054(21)2791, (01)00884838059054(21)1547, (01)00884838059054(21)2772, (01)00884838059054(21)657; 11. Allura Xper FD20; Model: 722028; UDI: (01)00884838054202(21)1756, (01)00884838054202(21)1569, (01)00884838054202(21)1956, (01)00884838054202(21)2206, (01)00884838054202(21)1233, (01)00884838054202(21)928, (01)00884838054202(21)2502, (01)00884838054202(21)1774, (01)00884838054202(21)869, (01)00884838054202(21)1017, (01)00884838054202(21)1957, (01)00884838054202(21)2261, (01)00884838054202(21)866, (01)00884838054202(21)1310, (01)00884838054202(21)1043, (01)00884838054202(21)1077, (01)00884838054202(21)995, (01)00884838054202(21)896, (01)00884838054202(21)877, (01)00884838054202(21)1439, (01)00884838054202(21)1343, (01)00884838054202(21)895, (01)00884838054202(21)1154, (01)00884838054202(21)1000, (01)00884838054202(21)1909, (01)00884838054202(21)1716, (01)00884838054202(21)1983, (01)00884838054202(21)2061, (01)00884838054202(21)1393, (01)00884838054202(21)1656, (01)00884838054202(21)1461, (01)00884838054202(21)1751, (01)00884838054202(21)1050, (01)00884838054202(21)1428, (01)00884838054202(21)1094, (01)00884838054202(21)2173, (01)00884838054202(21)1214, (01)00884838054202(21)52, (01)00884838054202(21)994, (01)00884838054202(21)1213, (01)00884838054202(21)1836, (01)00884838054202(21)982, (01)00884838054202(21)1646, (01)00884838054202(21)1396, (01)00884838054202(21)1394, (01)00884838054202(21)1650, (01)00884838054202(21)2275, (01)00884838054202(21)1058, (01)00884838054202(21)1353,

Distribution pattern

Domestic: Nationwide; International: Canada, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Ethiopia, Finland, France, French Polynesia, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Republic of, Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Malaysia, Maldives, Malta, Martinique, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Viet Nam, Yemen;

device · product 3 of 3

Integris-Allura system; System Code Description (Model Numbers): Integris CV Cesar-Powerpack-Visub-Nicol (722030), Integris Allura 15 & 12 (monoplane) (722043), INTEGRIS Allura 15-12 (biplane) (722044), Integris-Allura 9 (722018), Integris-Allura 9 (Biplane) (722021), Integris CV Cesar-Powerpack (722030), Integris H5000 C / Allura 9C (722016);

Z-2229-2026
Recall number
Z-2229-2026
Initiated
April 28, 2026
Classification
Class II
Status
Ongoing
Quantity
25 units (11 US, 14 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and displays the message Low load fluoroscopy flavor selected: Tube cooler problem . This condition cannot be resolved by restarting the system.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

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Inspect official wording and provenance

Reason for recall

The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and displays the message Low load fluoroscopy flavor selected: Tube cooler problem . This condition cannot be resolved by restarting the system.

Code information

1. Integris CV Cesar-Powerpack-Visub-Nicol; Model: 722030; UDI-DI: N/A; Serial Numbers: 4888270, 59, 0, 33; 2. Integris Allura 15 & 12 (monoplane) (722043); UDI-DI: N/A; Serial Numbers: 365, 18151, 176, 239, 407, 426, 0; 3. INTEGRIS Allura 15-12 (biplane) (722044); UDI-DI: N/A; Serial Numbers: 86322, 30, 66; 4. Integris-Allura 9 (722018); UDI-DI: N/A; Serial Numbers: 26, 85; 5. Integris-Allura 9 (Biplane) (722021); UDI-DI: N/A; Serial numbers: 22, 75, 25, 108; 6. Integris H5000 C / Allura 9C (722016); UDI-DI: N/A; Serial Numbers: 4059001008, 4807240, S01H003553/000001;

Distribution pattern

Domestic: Nationwide; International: Canada, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Ethiopia, Finland, France, French Polynesia, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Republic of, Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Malaysia, Maldives, Malta, Martinique, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Viet Nam, Yemen;