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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 3 M12; Catalog numbers: (1) 722063, (2) 722221. 1 02/20/2025 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 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY); 1 02/20/2025 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 7 B12; Catalog numbers: (1) 722067, (2) 722225, (3) 722235 (OUS ONLY). 1 02/20/2025 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236. 1 02/20/2025 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY). 1 02/20/2025 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.
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.
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