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Product Description
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Recall Class
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FDA Recall Posting Date
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Recalling Firm
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Z-0254-2016 - GE Healthcare, Discovery MR750w 3.0T.
Product Usage: The Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T Systems are whole body magnetic resonance scan...
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2
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11/10/2015
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FEI # 2126677 GE Healthcare
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Z-0255-2016 - GE Healthcare, SIGNA 3.0T.
Product Usage: Magnetic resonance system for diagnostic imaging. The indications for use for the 3.0T Signa VH/i (Signa 3.0T MR System) Transmit/Receive Body Imaging Coi...
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2
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11/10/2015
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FEI # 2126677 GE Healthcare
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Z-0256-2016 - GE Healthcare, SIGNA Excite 3.0T. MR System for use as a diagnostic imaging device.
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2
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11/10/2015
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FEI # 2126677 GE Healthcare
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Z-0260-2016 - GE Healthcare, SIGNA PET/MR 3.0T.
Product Usage:
The SIGNA PET/MR system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registr...
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2
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11/10/2015
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FEI # 2126677 GE Healthcare
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Z-0258-2016 - GE Healthcare, SIGNA HDx 3.0T. Product Usage: The GE Signa HDx MR system is a whole body magnetic resonance scanner for use as a diagnostic imaging device.
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2
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11/10/2015
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FEI # 2126677 GE Healthcare
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Z-0259-2016 - GE Healthcare, SIGNA HDxt 3.0T.
Product Usage:
The 1.5T Signa HDx family and 3.0T Signa HDx family are a whole body magnetic resonance scanner for use as a diagnostic imaging device.
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2
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11/10/2015
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FEI # 2126677 GE Healthcare
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Z-0257-2016 - GE Healthcare, SIGNA HD 3.0T. Product Usage: The Signa Profile EXCITE MR system is an open, whole body scanner for use as a diagnostic imaging device. It may be utilized for imaging during interventi...
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2
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11/10/2015
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FEI # 2126677 GE Healthcare
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