Recall Z-0413-06 ยท KPS System, Tomography, Computed, Emission
GE Healthcare
GE Millennium Systems: MC, MyoSight. Dual Head Gamma Camera. A compact cardiac-optimized nuclear imaging system. It is comprised of 2 digital CSE (Correlated Signal Enhancement) detectors in variable geometries mounted on a pass-through ring gantry, a compact imaging table, and a GENIE Acquisition station.
| Date | Jan 24, 2006 (initiated Apr 18, 2005) |
| Status | Terminated |
| Reason | In certain cases, one of the four collimator locking mechanisms that attach the collimator to the head may work itself free if collimator exchange has not been performed for an extended period of time. This situation, if neglected, could eventually cause the locking mechanism to unlock itself. |
| Root cause | Other |
| Action | Customer letter is being sent to all customers who have an affected system. The letter alerts customers of the potential release of the locking mechanism and requires a Weekly Collimator Exchange Procedure to avoid release of the locking latch until the permanent solution is made available. |
| Quantity | 1421 total for all affected Millenium Systems |
| Distribution | nationwide including Puerto Rico, and to countries including: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Denmark, Egypt, France, Germany, Iceland, India, Israel, Italy, Jordan, Korea, Kuwait, Luxembourg, Martinique, Mexico, New Zealand, Philippines Romania, Saudi Arabia, Sloveni |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K962738 | MILLENNIUM MT AND MILLENNIUM MG NUCLEAR MEDICINE SYSTEMS GE Medical Systems, Oct 10, 1996 |