Medical Device Recalls

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510(K) Number: K111445

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Product Description	Recall Class	FDA Recall Posting Date	Recalling Firm
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NM 830 Model # H3910AC	2	09/21/2020	FEI # 2126677 GE Healthcare, LLC
GE Nuclear Medicine 600/800 series systems, specifically: a) 830, b) 830 / Dismount, c) 830 /, ...	1	02/08/2023	FEI # 3004571294 GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
GE Healthcare Discovery NM 630, Model/Catalog Numbers: 1) 5376204-30-2, 2) H2401CF, 3) H2401C...	2	01/10/2025	FEI # 3004571294 GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
GE Discovery NM 630 The GE Discovery NM 630 system is a medical tool intended for use by appropr...	2	02/27/2012	FEI # 2126677 GE Healthcare, LLC
Discovery NM 630, dual detector free-geometry integrated nuclear imaging system. Product Usage:...	1	07/24/2013	FEI # 2126677 GE Healthcare, LLC
Discovery NM 630 (Model Number H3101RH), NM 830 (Model Number H3910AC), 830 NM Cyber Defense (Model ...	2	01/13/2021	FEI # 2126677 GE Healthcare, LLC
Discovery NM 630 Model # H3101RH	2	09/21/2020	FEI # 2126677 GE Healthcare, LLC
Discovery NM 630 Product Usage: The Discovery NM 630 is an all-purpose dual detector nuclear ima...	2	05/03/2019	FEI # 2126677 GE Healthcare, LLC