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 P
Check against the official notice below — it lists the full affected range.
GE Healthcare has recalled certain Discovery series PET scanners (models 600, 610, 690, and 710) due to a potential safety issue involving scatter overcorrection in the List Mode Replay feature. The recall affects 376 devices worldwide, including 101 in the United States across multiple states and 275 internationally distributed to countries including Canada, Australia, Japan, Germany, France, Brazil, and many others.
The recall record does not specify a remedy or instructions for affected consumers on how to address this issue.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: 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, JORDA Quantity: 376 (101 US, 275 OUS) Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.