Recall Z-2803-2015 ยท KPS System, Tomography, Computed, Emission
GE Healthcare
PET Discovery ST 16
| Date | Sep 21, 2015 (initiated Jul 17, 2015) |
| Status | Terminated |
| Reason | Potential for expulsion of the Power Supply on Lightspeed CT scanner or Discovery ST PET CT or Discovery LS PET CT scanner. |
| Root cause | Process control |
| Action | GE Healthcare sent an "Urgent Medical Device Correction" letter to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for the correction. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative. Ref# 25463 |
| Quantity | 18 |
| Distribution | Worldwide Distribution - US (nationwide) and to the countries of : ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CHINA, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY, HUNGRY, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN, REPUBLIC OF KOREA, MEXICO, NORWAY, POLAND, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH A |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041543 | GE DISCOVERY ST GE Healthcare, Jun 22, 2004 |