FDA Device recall Z-1053-2016
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…
- FDA Device
- Class II
- terminated
- Published 2016-03-16
On 2016-03-16 the FDA classified a Class II recall of 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… by Ge Medical Systems, citing GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an incorrect torque value.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1053-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-02-10 |
| Published | 2016-03-16 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ge Medical Systems |
| Distribution | US |
Product
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 Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery ST is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery ST system can also be used as a stand-alone head and whole body multi-slice computed tomography (CT) diagnostic imaging system. LightSpeed Pro16 - The Lightspeed 5.0 CT Scanner System is indicated for head and whole body X-ray computed tomography applications. 16 Slice BGO PET/CT System - The GE Discovery XR and XA Systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery XR and XA are to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. These devices can also assist in radiotherapy planning. The Discovery XR and XA can also be used as stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging systems. 6 Slice BGO PET/CT System - The GE Discovery LS System is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery LS is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery LS can also be used as a stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging system.
Reason
GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an incorrect torque value.
Identifiers
| code_info | Mfg Lot or Serial # System ID 00000006841PT1 PET368725CN8 00000004411PT5 4512-1 00000004411PT5 4512-1 00000006841PT…Mfg Lot or Serial # System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|
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1053-2016%22
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