FDA Device recall Z-1051-2016
LightSpeed 16 (MDAS only , , 2339985 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whol…
- FDA Device
- Class II
- terminated
- Published 2016-03-16
On 2016-03-16 the FDA classified a Class II recall of LightSpeed 16 (MDAS only , , 2339985 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whol… 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-1051-2016 |
| 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 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 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 00000350495CN8 A5333025 00001001853YM9 AL4004CT01 00000953838YM0 AL4023CT01 000010018…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 08242112019 |
|---|
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-1051-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.