GE Healthcare (China) Co., Ltd. recalls GE Healthcare Revolution Maxima, Model Numbers: 1) 666500

Hazard / Issue

GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if applicable) scan modes, after the first image of an exam, each subsequent image can be rotated by an increasing amount. The amount of progressive image rotation is dependent on the gantry speed and the duration of the scan. The final image in the exam can be rotated up to a maximum of ~56 degrees. The entire anatomy rotates as a whole by equal degrees, without distortion, and the anatomical positioning and z-axis of the images remains correct. Small degrees of image rotation might not be noticed. If image rotation is noticed and necessitates a rescan of the patient, the same image rotation will reoccur.

Issued by

FDA

Distribution: Worldwide distribution.

Lot/Code Info: 1) 6665000-2, UDI/DI 00840682146180, Serial/Sales Order Numbers: CBDMG2400130HM, CBDMG2400134HM; 2) 6670000-2, UDI/DI 00840682146180, Serial/Sales Order Numbers: CBDMG2400114HM, CBDMG2400127HM, CBDMG2400128HM, CBDMG2400129HM, CBDMG2400131HM, CBDMG2400132HM, CBDMG2400133HM, CBDMG2400135HM, CBDMG2400136HM, CBDMG2400137HM, CBDMG2400138HM, CBDMG2400139HM, CBDMG2400140HM, CBDMG2400141HM, CBDMG2400142HM, CBDMG2400143HM, CBDMG2400144HM, CBDMG2400145HM, CBDMG2400146HM, CBDMG2400147HM, CBDNG2400007HM, CBDNG2400010HM; UDI/DI 00195278686718, Serial/Sales Order Numbers: CBDOG2400032HM, CBDOG2400033HM, CBDOG2400034HM, CBDOG2400035HM; 3) 6670000-200, UDI/DI 00195278686718, Serial/Sales Order Numbers: CBFMG2400171HM, CBFMG2400188HM, CBFMG2400149HM, CBFMG2400160HM, CBFMG2400148HM, CBFMG2400173HM, CBFMG2400166HM, CBFMG2400185HM, CBFMG2400152HM, CBFMG2400156HM, CBFMG2400157HM, CBFMG2400158HM, CBFMG2400159HM, CBFMG2400163HM, CBFMG2400177HM, CBFMG2400178HM, CBFMG2400179HM, CBFMG2400180HM, CBFMG2400153HM, CBFMG2400154HM, CBFMG2400150HM, CBFMG2400182HM, CBFMG2400184HM, CBFMG2400161HM, CBFMG2400165HM, CBFMG2400172HM, CBFMG2400155HM, CBFMG2400162HM, CBFMG2400174HM, CBFMG2400176HM, CBFMG2400168HM, CBFMG2400151HM, CBFMG2400169HM, CBFMG2400170HM, CBFMG2400175HM, CBFMG2400181HM, CBFMG2400183HM, CBFMG2400186HM, CBFMG2400187HM, CBFMG2400164HM, CBFMG2400167HM; 4) 6670000-6, UDI/DI 00840682146180, Serial/Sales Order Numbers: MA10G2400033YC, MA10G2400032YC, MA10G2400034YC