Discovery ST, , 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 Positron Emissio
Check against the official notice below — it lists the full affected range.
GE Healthcare has issued a recall of 522 LightSpeed 4.0 CT Scanner Systems due to incorrect torque values in the Service Manuals. These scanners are used for head and whole body X-ray computed tomography applications and were distributed worldwide, including throughout the United States (except North Dakota, Vermont, and Wyoming) and in numerous countries internationally.
The recall affects specific scanner systems identified by their manufacturing lot and serial numbers. However, the recall record does not specify a remedy or the actions affected consumers or healthcare facilities should take.
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: 522 Lot/code info: Mfg Lot or Serial # System ID 00000312256CN1 4860LS16GS 00000312256CN1 4860LS16GS 00000312256CN1 4860LS16GS 00000294153CN2 0910212097 00000309306CN9 0910212101 00000309960CN3 0910212104 00000309960CN3 0910212104 00000311052CN5 0910212105 00000321402CN0 0910212106 00000321402CN0 0910212106 00000337340CN4 0910212115 00000337340CN4 0910212115 00000337340CN4 0910212115 00000297003CN6 0910213064 00000313645CN4 0910213070 00000301209CN3 0910215018 00000313097CN8 0910216036 00000337344CN6 0910216041 00000297460CN8 AH1410CT06 00000325191CN5 AH5362CT02 00000310728CN1 110037CT01 00000310728CN1 110037CT01 00000299935CN7 190020CT03 00000311058CN2 190052CT06 00000297386CN5 190059CT04 00000311058CN2 190052CT06 00000311426CN1 030018CT01 00000297596CN9 BA4142CT01 00000297596CN9 BA4142CT01 00000297596CN9 BA4142CT01 00000327271CN3 10026 00000346702CN4 1350651 00000310682CN0 2850998 00000310682CN0 2850998 00000327815CN7 CT327815CN7 00000332075CN1 BG4037CT01 UNK23399850000 BG4037CT01 00000316663CN4 BG4042CT01 00000316663CN4 BG4042CT01 00000327081CN6 BG4608CT01 00000314635CN4 BG4600CT01 00000357475CN3 CM1007CT02 00000357475CN3 CM1007CT02 00000357475CN3 CM1007CT02 00000361978CN0 082445020003 00000361978CN0 082445020003 00000361978CN0 082445020003 00000352887CN4 082445030003 00000347756CN9 082445100008 00000347756CN9 082445100008 00000309961CN1 082445150001 00000336259CN7 082445150008 00000359854CN7 082445160007 00000354676CN9 082445250002 00000294148CN2 HLGSCTD10002 00000294148CN2 HLGSCTD10002 000
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.