Z-0121-2013Class II

GE Discovery NM/CT670; GE Discovery NM 630

Name: Z-0121-2013 GE Discovery NM/CT670; GE Discovery NM 630
Creator: GE Healthcare, LLC
Published: 2012-10-12
License: https://open.fda.gov/license/

GE Healthcare / initiated 2012-10-12 / Terminated / root cause: software

FDA source

GE Healthcare, LLC began a recall of GE Discovery NM/CT670; GE Discovery NM 630 Product Usage: a medical tool intended for use by appropriately trained healthcare professionals to aid in... on 2012-10-12. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0121-2013
Classification: Class II
Status: Terminated
Initiated: 2012-10-12
Posted: 2012-10-23
Terminated: 2013-11-14
Recalling firm: GE Healthcare
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.
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: 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 tag: software
FDA 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 in commerce: 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.
Product 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,

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0121-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0121-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-31	2012-10-23

Product code KPS

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)