GE Healthcare, LLC: GE Discovery NM/CT670; GE Discovery NM 630 Product Usage: a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy. The GE Discovery NM/CT 670 system, combining Nuclear Medicine (NM) and Computed Tomography (CT) systems, is intended to produce: NM System: General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality.

Recall number

Z-0121-2013

Recalling firm

GE Healthcare, LLC

Product

GE Discovery NM/CT670; GE Discovery NM 630 Product Usage: a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy. The GE Discovery NM/CT 670 system, combining Nuclear Medicine (NM) and Computed Tomography (CT) systems, is intended to produce: NM System: General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality.

Status

Terminated

Initiated

2012-10-12

Posted

2012-10-23

Terminated

2013-11-14

Reason

GE Healthcare has recently become aware of a potential safety issue associated with the table pallet of your Discovery NM/CT 670 and/or Discovery NM630 system which may impact operation safety. At scan setup, during gantry rotation towards scanning position, a potential contact between the table-pallet-edge and the detector was identified. Such occurrence may damage the pallet front-edge and

Root cause

Software design

Action

GE Healthcare, LLC sent an " Urgent Medical Device Correction" letter dated October 12, 2012 to all affected customers. The letter was addressed to Managers of Nuclear Medicine, Hospital Administrators / Risk Mangers, and Mangers of Radiology / Cardiology. The letter described the Safety Issue, Safety Instructions, Affected Product Details and Product Correction. For questions or concerns contact your local GE Healthcare Service Representative. You may also contact GE Healthcare Call Center: United States or Canada: 800-437-1171 and Other countries: 262-896-2890.

Quantity

210

Distribution

Worldwide distribution: USA (Nationwide) in the states of: AL, CA, FL, GA, IL, IN, KS, LA, MD, MA, MN, MS, MO, NJ, NY, NC, OH, OK, PA, SC, TN, TX, VA, WI and WV. AUSTRALIA, BELGIUM, CANADA, CHINA, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GUADELOUPE, HONG KONG, INDIA, IRELAND, ISRAEL,ITALY, JAPAN, REPUBLIC OF KOREA, NETHERLANDS,NORWAY, POLAND, RUSSIAN FEDERATION, SPAIN, SWITZERLAND, TAIWAN,THAILAND, TURKEY, UNITED KINGDOM.

Lot, serial or model codes

Mfg Lot or Serial # 21058, 21002, 21013, 21017, 21020, 21029, 21039, 21041, 21049, 21066, 21075, 21079, 21080, 21081, 21082, 21119, 21140, 21144, 21145, 21147, 21150, 96BH8, 21001, 21008, 21034, 21050, 21056, 21104, 21132, 22003, 22020, 22038, 210088, 21042, 21048, 21061, 21077, 21085, 21094, 21115, 21122, 21123, 21137, 21143, 22051 21005, 21072, 21028, 21052, 21076, 21083, 21092, 21101, 21113, 21118, 21131, 21138, 21024, 22001, 22011, 22023, 21019, 21055, 21154, 83BH6 /000, 21007, 21047, 21009, 21021, 21022, 21033, 21035, 21037, 21063, 21064, 21067, 21070, 21073, 21086, 21095, 21121, 21128, 21134, 21141, 21146, 21152, 21153, 22014, 22016, 21003, 21006, 21010, 21027, 21036, 21043, 21046, 21051, 21084, 21108, 21116, 21120, 21124, 21133, 22015, 22028, 21093, 21158, 22021, 21031, 21129, 00ME1, 21004, 21014, 21053, 22005, 21012, 21059, 21151, 22022, 22031, 22035, 21089, 21100, 21136, 22044, 22071, 81BH0 /000, 82BH8 /000, 92BH7 /000, 93BH5 /000, 94BH3, 21016, 21040, 21060, 21103, 21125, 22037, 21038, 22008, 21068, 21126, 22009, 21026, 21011, 21018, 21025, 21071, 21090, 21109, 21110, 21130, 21142, 21160, 21096, 21107, 21091, 21099, 21000, 21023, 21030, 21032, 21044, 21045, 21054, 21062, 21065, 21069, 21074, 21105, 21111, 21114, 21127, 21149, 22002, 22004, 22007, 22010, 22012, 22017, 22018, 22024, 22025, 22026, 22027, 22029, 22030, 22032, 22033, 22034, 22036, 22039, 22040, 22041, 22042, 22043, 22045, 22046, 22047, 22048, 22049, 22050, 22052, 22053, 22054, 22056, 22057, 22059, 22064, 22067,

510(k) numbers

["K093514","K111445"]

PMA numbers

not on file

Product code

KPS

Firm FEI

2126677

Firm city

Waukesha

Firm state

WI

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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