PlainRecordsFDA · Medical device recall
GE Millennium Systems: MC… and 2 more products
- Date posted by the FDA
- Jan. 24, 2006
- Status
- Terminated
- Filed by
- GE Healthcare
- 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.
- Distribution pattern
- 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.
3 products in this recall
GE Millennium Systems: MC…
- Product
- 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.
- Quantity
- 1421 total for all affected Millenium Systems
- Codes and lots
- all serial numbers
- Recall started
- April 18, 2005
- Device type
- System, Tomography, Computed, Emission
- Root cause (FDA)
- Other
- What the company told customers
- 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.
- Recall number
- Z-0413-06
GE Millennium Systems: MG…
- Product
- GE Millennium Systems: MG. Multi-Geometry Digital CSE Dual Detector Gamma Camera. A modular nuclear medicine imaging system. The MG gantry allows the detectors to be oriented in the 180-degree and 101.25-degree orientations. The other modular core components include a 3-axis universal imaging table, a GENIE Acquisition station, dual Digital CSE (Correlated Signal Enhancement) detectors and high-performance collimators. Features optional real-time body-contoured SPECT and whole body scans, as well as ACuscan, an optional transmission attenuation correction system for SPeC and Gated SPECT scans.
- Codes and lots
- all serial numbers
- Recall started
- April 18, 2005
- Device type
- System, Tomography, Computed, Emission
- Root cause (FDA)
- Other
- What the company told customers
- 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.
- Recall number
- Z-0414-06
GE Millennium Systems: MPR and MPS Digital CSE Single Detector Gamma Camera…
- Product
- GE Millennium Systems: MPR and MPS Digital CSE Single Detector Gamma Camera. This system is a multi-purpose single-head nuclear medicine imaging system, comprised of a Digital CSE (Correlated Signal Enhancement) multi-purpose square detector, a pass-through counter-balanced ring gantry, a SPECT-optimized imaging table, and a collimator cart.
- Codes and lots
- all serial numbers
- Recall started
- April 18, 2005
- Device type
- System, Tomography, Computed, Emission
- Root cause (FDA)
- Other
- What the company told customers
- 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.
- Recall number
- Z-0415-06
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-0413-06, Z-0414-06, Z-0415-06. The agency record governs; check it and the company before acting.