Recall Z-2194-2017 ยท KPS System, Tomography, Computed, Emission
GE Healthcare, LLC
GE Healthcare Discovery NM/CT 670. 670 Pro, 670 ES X-ray system
| Date | May 19, 2017 |
| Status | Terminated |
| Reason | It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed. |
| Root cause | Software design |
| Action | GE Healthcare proposed action to bring defect into compliance : 1. Inform users of the potential for this issue to occur and instruct users as to the actions to take in the event of an Emergency Stop actuation during prep-delay. 2. Provide an update to product labeling for users that includes this information. GE Healthcare will include the updated product labeling with all current production systems. 3. Make modifications during the next scheduled product update to prevent this "race" condition from occurring in newly produced systems. CDRH approves the CAP subject to the followi |
| Quantity | 10,884 |
| Distribution | Worldwide Distribution - USA (nationwide) including Puerto Rico and to the countries of : Japan, Jordan, Kazakhstan, Korea ( Republic of) Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritania, Mexico, Moldova, Morocco, Nambia, Netherlands, New Caledonia, New |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093514 | DISCOVERY MODEL NM/CT 670 Ge Medical Systems F.I. Haifa, Dec 10, 2009 |