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U.S. Department of Health and Human Services

Class 1 Device Recall Discovery NM630

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 Class 1 Recall
Discovery NM630
see related information
Date Posted July 24, 2013
Recall Status1 Terminated on June 19, 2014
Recall Number Z-1791-2013
Recall Event ID 65579
Premarket Notification
510(K) Number
K111445 
Product Classification System, Tomography, Computed, Emission - Product Code KPS
Product Discovery NM 630, dual detector free-geometry integrated nuclear imaging system. Product Usage: The GE Discovery NM 630 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and in assessment of 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 630 system is a Nuclear Medicine (NM) system, which is intended to yield 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. The scanning modes include planar mode (Static, Multi-gated, Dynamic and Whole body scanning) and tomographic mode (SPECT, Gated SPECT, Whole body SPECT). The acquisition types include single and multi-isotope/ multi peak frame/list mode single-photon imaging. The imaging-enhancement features include assortment of collimators, gating by physiological signals, and real-time automatic body contouring. The GE Discovery NM 630 system may include signal analysis and display equipment, patient and equipment supports, components and accessories. The system may be used for patients of all ages.
Code Information System ID: 0850260134, 083026001113611, 00001NUC11, 00052NUC11, 030029NU05, 030151NU15, 030359NU07, 201418D630, 205333D630, 207664NM630, 208455NM630, 217544PH630, 251639D630, 262574D630, 269945D630, 270417D630, 281540D630, 301877D630, 305596D630A, 305596D630B, 317887D630, 318448D630, 318798D630, 319364D630A, 319364D630B, 330386D630, 334287NM630, 34363NUC01, 407431NU01, 409212NM630, 417533D630, 417781D630, 469814NM630, 580531NM630, 585922NM630, 601288D630, 601354D630, 601798D630, 609978D630, 614NCH630, 618443DISC1, 618842DISC1, 618942NM630, 619474D630, 651DSC630, 702388VNM2, 704355D630, 708684D630, 716372NM630, 719587D630, 770751D630, 773282D630, 801714D630, 804675D630A, 808485NM630, 813558D630, 813615D630, 814623D630, 815564D630, 816234D630, 843347D630, 843797TD630, 845454D630, 870939NU01, 870939NU02, 901226D630, 903GSD630, 904276DSC1, 904321DSC1, 905684D630, 913345D630, 918502DIS1, 936NMD630, 937SNHC630, 941LWRNM630, 956523D630, 978354DSV630, 989227D630, A5131865, A5366307, A5384208, A5812287, EG1040NM01, H002NU03, H3001NUC01, HC0863NU02, IE1018MN03, IE1044NM01, JHDSV630NM, M4216453, M4476428, M45052111, NM22073, NO1035MN06, NT3001, NT3002, NT3003, NT3010, NT3020, O009NU09, OSC630, PC3003NU01, PMAB01NU04, POIN630, PRINCE630, RTD0739, RU1136NM01, TP0004NU01.
Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
For Additional Information Contact technical services
262-513-4122
Manufacturer Reason
for Recall
GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System. UPDATE: On July 03, 2013 GE notified hospitals that they are recalling several Nuclear Medicine Imaging Systems because serious injuries or deaths could occur due to the failure mode associated with this re
FDA Determined
Cause 2
DESIGN: Device Design
Action GE sent an Urgent Medical Device Correction letter dated June 17, 2013 to all affected customers. The letter identified the affected product, recommended that qualified service personnel maintain the equipment and that Preventative Maintenance procedures are executed according to labeling. Also the Safety Chapter Sections should be re-reviewed with personnel to ensure proper operation of the equipment. GE notified customers again on July 03, 2013, via Urgent Medical Device Recall letter (including confirmation of delivery for US customers) and follow-up telephone call. Customers were instructed to cease using the affected system until GE Healthcare Field Engineer can complete an inspection of the system and perform any necessary repairs at no cost. A GE Healthcare representative will contact the hospitals to arrange for the inspection.
Quantity in Commerce 108
Distribution Worldwide Distribution - US Nationwide including Guam, Puerto Rico and the countries of : Afghanistan, Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Korea (Republic of), Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Malta, Martinique, Mexico, Morocco, Namibia, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, Uruguay, Venezuela, Vietnam.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KPS and Original Applicant = GE HEALTHCARE
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