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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 8 of 8 Results
510(K) Number: K063559
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Product Description
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FDA Recall
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Panorama 1.0T HFO, Magnetic Resonance (MR) System; Model Numbers 781250 and 781350. Philips Magnetic... 1 12/14/2023 Philips North America Llc
Achieva 1.5T 2 11/21/2023 Philips North America Llc
Intera 1.5T 2 11/21/2023 Philips North America Llc
Ingenia 1.5T CX 2 11/21/2023 Philips North America Llc
Achieva 1.5T Conversion 2 11/21/2023 Philips North America Llc
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.
3.7 V Li-Polymer Battery, used in Precess MRI Compatible Patient Monitoring System and Achieva, Inte... 2 02/06/2009 Invivo Corporation
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