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Product Description
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Recall Class
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FDA Recall Posting Date
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Recalling Firm
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Z-1349-2026 - Azurion 7 M20
System Model Numbers: (1)722079, (2)722224, (3)722234, (4)722282(OUS only);
Software Version Number - All versions: R1.X, R2.X, R3.X
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2
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02/11/2026
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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
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Z-1348-2026 - Azurion 7 M12
System Model Numbers: (1)722078, (2)722223, (3)722233;
Software Version Number - All versions: R1.X, R2.X, R3.X
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2
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02/11/2026
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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
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Z-1347-2026 - Azurion 7 B20
System Model Numbers: (1)722068, (2)722226, (3)722236;
Software Version Number - All versions: R1.X, R2.X, R3.X
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2
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02/11/2026
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
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Z-1346-2026 - Azurion 7 B12
System Model Numbers:(1) 722067, (2) 722225, (3) 722235;
Software Version Number - All versions: R1.X, R2.X, R3.X
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2
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02/11/2026
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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
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Z-1351-2026 - Azurion 5 M20
System Model Numbers: (1)722228, (2)722232, (3)722281(OUS only);
Software Version Number - All versions: R1.X, R2.X, R3.X
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2
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02/11/2026
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
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Z-1350-2026 - Azurion 5 M12
System Model Numbers: (1)722227, (2)722231;
Software Version Number - All versions: R1.X, R2.X, R3.X
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2
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02/11/2026
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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
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Z-1345-2026 - Azurion 3 M15
System Model Numbers: (1) 722064, (2) 722222, (3) 722230, (4)722280(OUS only);
Software Version Number - All versions: R1.X, R2.X, R3.X
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2
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02/11/2026
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
|
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Z-1344-2026 - Azurion 3 M12
System Model Numbers: (1) 722063, (2) 722221, (3) 722229;
Software Version Number - All versions: R1.X, R2.X, R3.X
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2
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02/11/2026
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
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