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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-0184-2015 - GE Healthcare Infinia (including Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye, Infinia II Hawkeye 4, Infinia II VC, Infinia II VC Hawkeye, and Infinia II VC Hawkeye 4) Models: H3000WC, H3...
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2
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12/16/2014
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GE Healthcare, LLC
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Z-0185-2015 - GE Healthcare Varicam/VG and VG Hawkeye devices. Models H3000YA, H3000YB, H3000YC, H3000YD, H2508PA, H2508PB, H2508PC, H2508PD.
Product Usage: The intended use of the Quasar system is to perfo...
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2
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12/16/2014
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GE Healthcare, LLC
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Z-0189-2015 - Brivo NM615, is an all-purpose, single detector integrated nuclear imaging system. Models H3100TP, H3100TN, H3100TT, H3100TR, H3100TW, H3100WZ, H2401MP, H2401MN, H2401MT, H2401MR, H2401MW, H2401NJ.
...
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2
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12/16/2014
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GE Healthcare, LLC
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Z-0187-2015 - Discovery NM 630, dual detector free-geometry integrated nuclear imaging system. Models H3100RC, H3100RD, H2401LW.
Product Usage: The GE Discovery NM 630 system is a medical tool intended for u...
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2
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12/16/2014
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GE Healthcare, LLC
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Z-0188-2015 - Optima NM/CT 640, Models H3100YA, H3100YC.
Product Usage: The GE Optima NM/CT 640 system is intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake i...
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2
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12/16/2014
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GE Healthcare, LLC
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Z-0186-2015 - Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging system. Models H3100NA, H3100PP, H3100RA, H2401LS, H2401LZ, H2402LS.
Product Usage: The GE Discovery NM/CT 670 system i...
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2
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12/16/2014
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GE Healthcare, LLC
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