CT LightSpeed 16 and Discovery ST Pet/CT DST. Catalogue # 2339985. Designed to be a head and w...
FDA Device Recall #Z-1623-2015 — Class II — April 22, 2015
Recall Summary
| Recall Number | Z-1623-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 22, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | GE Healthcare |
| Location | Waukesha, WI |
| Product Type | Devices |
| Quantity | 4 USA |
Product Description
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
Distribution Pattern
Distributed to the states of MN, FL & TX.
Lot / Code Information
Mfg Lot or Serial # System ID 00000331100CN8 904223CT 00000345975CN7 409838LS16 00000337343CN8 512OCCT 00000344962CN6 INSIGHTPCT1356
Other Recalls from GE Healthcare
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1475-2026 | Class II | GE Healthcare Centricity Universal Viewer Zero ... | Jan 16, 2026 |
| Z-1487-2025 | Class II | GE Healthcare Centricity Centricity PACS-IW wit... | Feb 19, 2025 |
| Z-1484-2025 | Class II | GE Healthcare Centricity PACS-IW (PACS-IW), Mod... | Feb 19, 2025 |
| Z-1486-2025 | Class II | GE Healthcare Centricity Cardiology CA1000 (CA1... | Feb 19, 2025 |
| Z-1485-2025 | Class II | GE Healthcare Centricity Radiology RA600 (RA600... | Feb 19, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.