FDAFDA · Food and drugs·Recall number Z-0981-2014
GE Healthcare, PET Discovery 610, Discovery 710, Discovery 600 and Discovery 690. The GE Discovery XR and XA Systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery XR and XA are to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. These devices can also assist in radiotherapy planning. The Discovery XR and XA can also be used as stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging systems.
Published February 26, 2014 · Recall initiated: November 20, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
GE Healthcare has recently become aware of a potential safety issue due to scatter overcorrection associated with the List Mode Replay feature of your Discovery 600, 610, 710 and Discovery 690.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- GE Healthcare, LLC
- Distributor
- Worldwide Distribution - USA including AL, AZ, AR, CA, CO, FL, GA, IL, IN, IA, KY, LA, MN, MO, NE, NJ, NM, NY, NC, OH, OK, PA, SD, TN, TX, UT, VA, WA, WV, WI and Internationally to: AUSTRALIA, AUSTRIA BELGIUM BOSNIA AND HERZEGOVINA, BRAZIL, CANADA, CHILE, COLOMBIA, CHINA, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, FRANCE, FINLAND, GEORGIA, GERMANY, HONG KONG, IRAN, ISRAEL INDIA,M ITALY, JAPAN, JORDAN, KUWAIT, LEBANON, MALAYSIA, MEXICO, MOROCCO, NEW ZEALAND, NORWAY, RUSSIA, REPUBLIC OF KOREA, POLAND, ROMANIA, SAUDI ARABIA, SPAIN, SWEDEN SWITZERLAND, TAIWAN, TUNISIA, THAILAND, TURKEY, UNITED KINGDOM.
- Lot
- FMI 13715 Serial # System ID 00000012391PT9 530UCVETPET 00000012525PT2 RHCDISC710 00000012544PT3 856247PETUPS 00000012561PT7 505216D710 00000012574PT0 858805PCT 00000012615PT1 630432D710 00000012674PT8 801581D710 00000012723PT3 602839D710 00000012732PT4 402327D610 00000012752PT2 719365PETCT 00000012771PT2 414805D710 00000012834PT8 904710PET 00000012843PT9 918505PETCT1 00000012849PT6 205975PET1 00000012865PT2 205975PET2 00000012896PT7 985542D610 00000012915PT5 256386HKPETCT 00000012924PT7 318675D710 00000012937PT9 504842D600 00000012961PT9 303673PETCT 00000012975PT9 605328D710 00000013017PT9 608WIMRD710 00000013057PT5 847872D610 00000013066PT6 4056793 00000013067PT4 212288DST710 00000013072PT4 002902086 00000013081PT5 253968D710 00000013101PT1 270688PETCT 00000012473PT5 910452029 00000012749PT8 910456003 00000012837PT1 83095572097 00000012888PT4 83092720723 00000013026PT0 83092879582 00000012626PT8 AH0132PE01 00000012774PT6 306655D710 00000012533PT6 CT428868CN4 00000012900PT7 EGL067 00000012538PT5 HC1992PE01 00000012582PT3 DK1043PT02 00000012819PT9 DK1054PT17 00000012963PT5 EG1017PT01 00000012993PT2 EG1525PT01 00000012822PT3 A4166968 00000012970PT0 M9886853 00000013082PT3 M4145026 00000013099PT7 EGL110 00000012717PT5 8.30458E+13 00000012722PT5 8.3045E+13 00000012738PT1 8.3045E+13 00000012871PT0 4065738 00000012881PT9 4108707 00000012909PT8 83045062157413 00000012921PT3 8.30452E+13 00000013020PT3 8.30452E+13 00000013127PT6 4119154 00000012600PT3 A5124541 00000012638PT3 A5367810 00000012644PT1 A5366305 00000012655PT7 B5801736 00000012756PT3 A51142135 00000012877PT7 A51051131 00000012887PT6 A51273167 00000012930PT4 A5330720 , A5330718 , A5330719 00000012940PT3 B5315353 00000013023PT7 B5811440 00000012553PT4 GQF002 00000012568PT2 SQF701 00000012585PT6 GQF001 00000012649PT0 SQF001 00000012735PT7 GQF003 00000012766PT2 GQF004 00000012807PT4 SQF710 00000012811PT6 GQ0001 00000012951PT0 SQF003 00000013048PT4 EGL098 00000013078PT1 EGL106 00000013112PT8 EGL116 00000013118PT5 EGL117 00000012599PT7 850450166 00000012665PT6 850450167 00000012788PT6 850450169 00000012801PT7 PL1674PT01 00000012996PT5 PL3057PT01 00000013008PT8 PL2711PT01 00000013038PT5 PL3040PT01 00000013075PT7 EGL105 00000013054PT2 RO1252PT01 00000013014PT6 PET13014PT6 00000012589PT8 34339PET01 00000012868PT6 34367PET01 00000012913PT2 00060DST05 00000012925PT4 00060DST04 00000012931PT2 00060CTS02 00000013007PT0 00040DST01 FMI 13716 Serial # System ID 00000001240PT5 262574DST3 00000011146PT8 717657CTPT 00000011218PT5 631MSKPCTD600 00000011233PT4 845695PCT600 00000011344PT9 718370DST6 00000011428PT0 386586FHD600 00000011472PT8 928788PETCT 00000011491PT8 405271PET2 00000011531PT1 386943FHDD600 00000011556PT8 262434D600 00000011565PT9 417347PET 00000011603PT8 479936PETHOG 00000011628PT5 813745D600 00000011636PT8 937771PCT 00000011650PT9 562826D600 00000011653PT3 201858PT600 00000011713PT5 425952D600 00000011714PT3 813396D600 00000011807PT5 626AHMC560 00000011815PT8 520AZO560 00000011870PT3 626COH560 00000011877PT8 RADNETPT1826 00000011912PT3 805739PET1 00000011919PT8 219879PET 00000011923PT0 201858PT2 00000011934PT7 704225PET 00000011937PT0 256308PET 00000011938PT8 RADNETPT619 00000011939PT6 985649D600 00000012244PT0 510537PET 00000012440PT4 770400PCT 00000010847PT2 520UMID690 00000011014PT8 515643D690 00000011240PT9 214370D690 00000011243PT3 312996D690 00000011297PT9 212639PETD690 00000011339PT9 713563D690 00000011435PT5 3154PCT690 00000011460PT3 309672PCT 00000011463PT7 951704PTCT 00000011508PT
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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