GE Millennium Systems: MG. Multi-Geometry Digital CSE Dual Detector Gamma Camera. A modular nuclear medicine imaging sys
FDA device recall Z-0414-06 · posted 2006-01-24 · Terminated
Recall details
- Recalling firm
- GE Healthcare
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- KPS
- 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, Kor
- Date initiated
- 2005-04-18
- Date posted
- 2006-01-24
- Date terminated
- 2008-02-24
- Location
- Waukesha, WI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MILLENNIUM MT AND MILLENNIUM MG NUCLEAR MEDICINE SYSTEMS (K962738) | GE Medical Systems | 1996-10-10 |