LightSpeed Ultra (8-slice MDAS), 5120327-3 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 correct
Check against the official notice below — it lists the full affected range.
GE LightSpeed Ultra CT Scanner Service Manual Update
GE Healthcare has issued a recall of 25 LightSpeed Ultra (8-slice MDAS) 5120327-3 LightSpeed 4.0 CT Scanner Systems due to an incorrect torque value in the Service Manuals. The affected systems have been distributed worldwide, including throughout the United States (except North Dakota, Vermont, and Wyoming), Puerto Rico, and numerous countries across Europe, Asia, South America, Africa, and the Middle East. The specific serial numbers and lot codes for all 25 affected units are documented in the recall notice.
The record does not specify a remedy or corrective action that consumers should take regarding this recall.
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: 25 Lot/code info: Mfg Lot or Serial # System ID 00001035638YM4 082421010179 00000001887YC9 082421010327 00001035639YM2 082421020108 00001035636YM8 082421020109 00001031633YM9 082421030253 00001031634YM7 082421030254 00000003852YC1 082421030266 00001031640YM4 082421040157 00001035634YM3 082421060051 00000001885YC3 082421060054 00001035641YM8 082421080078 00001031632YM1 082421090164 00001035640YM0 082421090168 00001031639YM6 082421100318 00001031638YM8 082421120200 00000003853YC9 082421140187 00001031637YM0 082421150068 00000001883YC8 082421200244 00000001888YC7 082421270069 00001035633YM5 082421310091 00000001891YC1 082421040171 00000001892YC9 082421040177 00000001889YC5 082421090174 00000001890YC3 082421090175 00000001886YC1 082421310106
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.