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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 10 of 34 Results
510(K) Number: K102005
 
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The following systems are only affected if a Laird chiller is installed (11NC: 98960021599): Allura ... 2 04/14/2017 Philips Electronics North America Corporation
Product Name: Allura Xper FD10C; Model number: 722001; 2 01/13/2026 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Medical System Allura Xper X-Ray Angiographic 2 03/02/2015 Philips Medical Systems, Inc.
Philips Allura System configured with a 1 Phase UPS. Allura family (R1.x, R2.x). Labeled as the ... 2 09/03/2025 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Interventional Fluoroscopic X-Ray System - Philips Allura Xper Series. Labeled as the following with... 2 09/03/2025 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20; Model Number: 722028; 2 01/13/2026 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20; Model Number: 722012; 2 01/13/2026 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20; Model Number: 722006; 2 01/13/2026 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20/20; Product Code: 722038; Associated 510(k) numbers: K102005, K130842, K130638, K13... 2 09/25/2025 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20/20; Model Number: 722038; 2 01/13/2026 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
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