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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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Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026, 1 02/20/2025 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028. 1 02/20/2025 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 2 09/07/2023 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 3 M12; Catalog numbers: (1) 722063, (2) 722221. 1 02/20/2025 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 M15; Catalog numbers: (1) 722064, (2) 722222 (3) 722280(OUS ONLY). 1 02/20/2025 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.
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 5 M20; Catalog numbers: (1) 722228, (2) 722232 (OUS ONLY), (3) 722281 (OUS ONLY). 1 02/20/2025 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
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