LightSpeed QX/I (4-slice MDAS) 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
Check against the official notice below — it lists the full affected range.
GE Healthcare issued an update to Service Manuals for multiple CT and PET CT Scanner models, including the LightSpeed QX/I and LightSpeed 4.0 systems, to correct an incorrect torque value in the documentation. A total of 104 affected systems were distributed worldwide across the United States (excluding North Dakota, Vermont, and Wyoming), Puerto Rico, and numerous countries including Canada, Australia, China, India, and many others.
The recall record does not specify a remedy or required action for consumers or healthcare facilities affected by 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: 104 Lot/code info: Mfg Lot or Serial # System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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.