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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 10 of 32 Results
510(K) Number: K172822
 
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Azurion 5 M20 System Model Numbers: (1)722228, (2)722232, (3)722281(OUS only); Software Version Nu... 2 02/11/2026 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 7 M20 System Model Numbers: (1)722079, (2)722224, (3)722234, (4)722282(OUS only); Software... 2 02/11/2026 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 7 M12 System Model Numbers: (1)722078, (2)722223, (3)722233; Software Version Number - All... 2 02/11/2026 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 7 B20 System Model Numbers: (1)722068, (2)722226, (3)722236; Software Version Number - All... 2 02/11/2026 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 7 B12 System Model Numbers:(1) 722067, (2) 722225, (3) 722235; Software Version Number - A... 2 02/11/2026 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 3 M15 System Model Numbers: (1) 722064, (2) 722222, (3) 722230, (4)722280(OUS only); Softw... 2 02/11/2026 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Software Version Number - ... 2 02/11/2026 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version Number - All versions: ... 2 02/11/2026 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes the following label des... 2 01/14/2026 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x). Labeled as the fo... 2 09/03/2025 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
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