GE Discovery NM/CT670…

Date

Oct. 31, 2012

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Terminated

Filed by

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.

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

Distribution pattern

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.

Quantity

210

Codes and lots

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,

Recall started

Oct. 12, 2012

Device type

System, Tomography, Computed, Emission

Root cause (FDA)

Software design

What the company told customers

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.

Recall number

Z-0121-2013

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-0121-2013. The agency record governs; check it and the company before acting.