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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 Systemssee related information
Date Initiated by FirmApril 18, 2005
Date PostedJanuary 24, 2006
Recall Status1 Terminated 3 on February 24, 2008
Recall NumberZ-0413-06
Recall Event ID 33062
510(K)NumberK962738 
Product Classification System, Tomography, Computed, Emission - Product Code KPS
ProductGE 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.
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
ActionCustomer 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 in Commerce1421 total for all affected Millenium Systems
Distributionnationwide 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 CycleTPLC 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) Database510(K)s with Product Code = KPS
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