Recall Z-0012-05 ยท KPS System, Tomography, Computed, Emission
General Electric Med Systems LLC
Emission Computed Tomography System. Including Model numbers: 2200967, ASM001080, ASM001083, ASM001092, ASM001099, ASM000085, 10036800109, and Varicam.
| Date | Oct 7, 2004 (initiated Sep 3, 2004) |
| Status | Terminated |
| Reason | GE Healthcare received reports of intermittent low ejection fraction (EF) results for MUGA (multi-gated acquisitions) studies on Millennium VG systems. This issue can occasionally lead to distortions in the volume curve in some MUGA studies, and result in calculated EF values lower (never higher) than actual values. A low EF value could lead to a physician decision to stop needed treatment. |
| Root cause | Other |
| Action | A letter dated August 5, 2004 was released to customers describing the issue and recommending that users pay special attention to any volume curve which appears to be abnormal or any EF values that appear to be lower than expected, and not to rely soley on this value for diagnosis purposes until they recieve the SW patch. A SW patch will be distributed shortly to all affected systems. |
| Quantity | 853 units |
| Distribution | Nationwide throughout the United States and worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K953801 | VARICAM Elscint, Inc., Nov 22, 1995 |