CT LightSpeed 16 and Discovery ST Pet/CT DST — Class II medical device recall Z-1623-2015
Terminated recall by GE Healthcare, reported 2015-05-27, distributed in FL, MN, TX. GE Healthcare has become aware that 3 bolts that secure a power supply to the rotating side of the gantry were
| Recall number | Z-1623-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, Waukesha, WI, United States |
| Recall initiated | 2015-04-22 |
| Classified | 2015-05-15 |
| Reported by FDA | 2015-05-27 |
| Terminated | 2015-07-15 |
| Distributed | FL, MN, TX |
| Quantity | 4 usa |
| Model numbers | 2339985 |
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 for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1623-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.