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U.S. Department of Health and Human Services

Medical Device Recalls
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IBA Proton Therapy System - PROTEUS 235 - Designed to produce and deliver a proton beam for the trea... 2 06/03/2024 Ion Beam Applications S.A.
The Synchro Neuro Guidewires are a steerable guidewire family with a shapeable tip. The outside diam... 2 05/31/2024 Stryker Neurovascular
The Synchro2 Guidewires are a steerable guidewire family with a shapeable tip and are available in s... 2 05/31/2024 Stryker Neurovascular
The Synchro SELECT Guidewires are a steerable guidewire family with a shapeable tip and are availab... 2 05/31/2024 Stryker Neurovascular
RefleXion X1 Radiotherapy System Model RXM1000 Software version 2.1.19-3 Radiation therapy system i... 2 05/30/2024 Reflexion Medical, Inc.
FDR Visionary Suite - Intended to generate digital or conventional radiographic images of the skull... 2 05/24/2024 FUJIFILM Healthcare Americas Corporation
Upgrade dStream - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use a... 2 05/17/2024 Philips North America Llc
Evolution upgrade 3.0T Model Number (REF): (1)782117; (2) 782143 2 05/17/2024 Philips North America Llc
Evolution upgrade 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated fo... 2 05/17/2024 Philips North America Llc
MR RT Upgrades- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as ... 2 05/17/2024 Philips North America Llc

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