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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 10 of 18 Results
510(K) Number: K110151
 
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Ingenia 1.5T- a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic devi... 2 09/03/2021 Philips North America Llc
Achieva 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device... 2 08/25/2021 Philips North America Llc
MR-OR 3.0T, Model Number 781438. Nuclear Magnetic Resonance Imaging System 2 02/22/2019 Philips Medical Systems Nederlands
MR RT, Model Number 781439. Nuclear Magnetic Resonance Imaging System 2 02/22/2019 Philips Medical Systems Nederlands
MR-OR 1.5T, Model Number 781437. Nuclear Magnetic Resonance Imaging System 2 02/22/2019 Philips Medical Systems Nederlands
Ingenia MR-OR; 781437, 781438 The MR-OR option is intended for allowing transfer of a neurosurgical... 2 12/19/2016 Philips Electronics North America Corporation
Ingenia, Intera, Achieva and Achieve dStream MR systems on Software versions R5.1.7 and R5.1.8 with... 2 11/23/2015 Philips Medical Systems, Inc.
All Philips Ingenia, Intera, Achieva and Multiva MR systems using R5.1i and R5.1 .2 version of softw... 2 10/19/2015 Philips Medical Systems, Inc.
IntelliSpace Portal (ISP) DX/HX/EX, IntelliSpace Portal (ISP) IX, and IntelliSpace Portal (ISP) LX S... 2 08/14/2014 Philips Medical Systems (Cleveland) Inc
Ingenia 3.0T, magnetic resonance imaging system. 2 06/24/2014 Philips Medical Systems, Inc.
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