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U.S. Department of Health and Human Services

Class 2 Device Recall Millennium Nuclear Medicine Systems

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  Class 2 Device Recall Millennium Nuclear Medicine Systems see related information
Date Initiated by Firm April 18, 2005
Date Posted January 24, 2006
Recall Status1 Terminated 3 on February 24, 2008
Recall Number Z-0414-06
Recall Event ID 33062
510(K)Number K962738  
Product Classification System, Tomography, Computed, Emission - Product Code KPS
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.
Code Information all serial numbers
Recalling Firm/
Manufacturer		 GE Healthcare
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
262-544-3894
Manufacturer 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.
FDA Determined
Cause 2		 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.
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, Slovenia, South Africa, Spain, Sweden, Taiwan and United Kingdom.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KPS and Original Applicant = GE MEDICAL SYSTEMS
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