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.
Recall
- Recall Number
- Z-0413-06
- Event Number
- 33062
- Firm
- GE Healthcare
- FEI Number
- 2126677
- Product Code
- KPS
- Status
- Terminated
- Root Cause
- Other
- Initiated
- April 18, 2005
- Posted
- January 24, 2006
- Terminated
- February 24, 2008
- Address
- 3000 N Grandview Blvd, Waukesha, WI, 53188-1615
Description
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.
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.
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.
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, Slovenia, South Africa, Spain, Sweden, Taiwan and United Kingdom.
1421 total for all affected Millenium Systems