LightSpeed 16 (MDAS only , , 2339985 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body attenuation corrected Pos
Check against the official notice below — it lists the full affected range.
GE Healthcare issued a recall affecting 324 LightSpeed 16 and LightSpeed 4.0 CT Scanner Systems worldwide because the Service Manuals for these devices contained an incorrect torque value. The recalled systems were distributed throughout the United States (except North Dakota, Vermont, and Wyoming), Puerto Rico, and numerous countries internationally.
The recall notice does not specify a remedy for affected consumers or facilities using these scanners.
Written by software from the official notice below. Not reviewed by a lawyer.
GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an incorrect torque value.
Reason for recall: GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an incorrect torque value. Distribution: Worldwide Distribution - US including all states in including PR except ND, VT & WY. Foreign Distribution: ALBANIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BOSNIA & HERZEGOVINA, BRAZIL, BULGARIA, BURKINA FASO, CAMERON, CANADA, CHILE, CHINA, COLOMBIA, DOMINICAN REPUBLIC, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE,HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRA N, IRAQ, IRELAND, ISRAEL Quantity: 324 Lot/code info: Mfg Lot or Serial # System ID 00000350495CN8 A5333025 00001001853YM9 AL4004CT01 00000953838YM0 AL4023CT01 00001001879YM4 0002876927 00000357924CN0 1577LS16 00001001879YM4 0002876927 00001001879YM4 0002876927 00001001879YM4 0002876927 00001010424YM8 0910212127 00001010461YM0 0910212129 00001010461YM0 0910212129 00001010471YM9 0910213084 00000980093YM9 0910212119 00000980093YM9 0910212119 00000994084YM2 0910212123X 00000984698YM1 0910213080 00001010387YM7 0910215023 00001010475YM0 0910215025 00001001897YM6 AH5703CT01 00000980120YM0 AH4001PE01 00000988410YM7 110002CT02 00000953828YM1 110017CT01 00000980106YM9 110040CT03 00000953853YM9 110059CT01 00000988410YM7 110002CT02 00000980111YM9 030355CT03 00000980111YM9 030355CT03 00001002103YM8 2858149 00000383739CN0 CT383739CN0 00000980108YM5 BF1012CT01 00000980108YM5 BF1012CT01 00000980108YM5 BF1012CT01 00000988391YM9 CT988391YM9 00000988391YM9 CT988391YM9 00000988391YM9 CT988391YM9 00001002107YM9 082421120191 00000364134CN7 082445160009 00000365398CN7 082445040002 00000363607CN3 082421100316 00001002106YM1 082421110048 00000953856YM2 082421120171 00001001852YM1 082421120187 00001010423YM0 082421100294 00001010444YM6 082421100301 00000941008YM5 082421020154 00000988393YM5 082421030172 00000996079YM0 082421030175 00000988398YM4 082421050047 00000996082YM4 082421100157 00000984688YM2 082421100270 00000988395YM0 082421100276 00000988397YM6 082421100278 00000984685YM8 082421100283 00001010426YM3 082421160169 00001010436YM2 082421160176 00
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.