Recall Z-1051-2016 ยท KPS System, Tomography, Computed, Emission
GE Medical Systems, LLC
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
| Date | Feb 10, 2016 |
| Status | Terminated |
| Reason | GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an incorrect torque value. |
| Root cause | Labeling design |
| Action | GE Healthcare sent an Urgent Medical Device Correction letter " GEHC Ref# 25467-ABT or 25467" dated February 12, 2016, to all affected consignees . The letter was addressed to Hospital Administrators / Risk Managers, Managers of Radiology/Cardiology, & Radiologist/Cardiologist. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. Consignees were instructed to ensure that the organization that service their equipment uses the latest version of the Service Manual to maintain the safe and proper performance of thei |
| Quantity | 324 |
| Distribution | Worldwide Distribution - US including all states in including PR except ND, VT & WY. Foreign Distribution: ALBANIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BOSNIA & HERZEGOVINA, BRAZIL, BULGARIA, BURKINA FASO, CAMERON, CANADA, CHILE, CHINA, COLOMBIA, DOMINICAN REPUBLIC, ESTONIA, FINLAND, FRANCE, GE |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081496 | OPTIMA PET/CT 560 Ge Medical Systems, LLC, Jun 12, 2008 |