FDA Device recall Z-1623-2015
CT LightSpeed 16 and Discovery ST Pet/CT DST. Catalogue # 2339985
- FDA Device
- Class II
- terminated
- Published 2015-05-27
On 2015-05-27 the FDA classified a Class II recall of CT LightSpeed 16 and Discovery ST Pet/CT DST. Catalogue # 2339985 by Ge Healthcare, citing GE Healthcare has become aware that 3 bolts that secure a power supply to the rotating side of the gantry were over-torqued on certain Lightspeed 16 CT scanner or PET/CT DST Scann….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1623-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-04-22 |
| Published | 2015-05-27 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | FL, MN, TX |
Product
CT LightSpeed 16 and Discovery ST Pet/CT DST. Catalogue # 2339985. Designed to be a head and whole body CT scanner utilizing a new solid state detector.
Reason
GE Healthcare has become aware that 3 bolts that secure a power supply to the rotating side of the gantry were over-torqued on certain Lightspeed 16 CT scanner or PET/CT DST Scanner.. In the unlikely event that the component becomes loose on the CT gantry during operation, it could result in serious bodily injury if the component were expelled. There were no incidents or injuries reported as a res
Identifiers
| code_info | Mfg Lot or Serial # System ID 00000331100CN8 904223CT 00000345975CN7 409838LS16 00000337343CN8 512OCCT 00000344962CN6 INSIGHTPCT1356 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1623-2015%22
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