—#43766

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.

FDA product code: KPS — System, Tomography, Computed, Emission
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K962738
Affected lot / code info: all serial numbers

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: GE Healthcare
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

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.

Timeline

Recall initiated: 2005-04-18
Posted by FDA: 2006-01-24
Terminated: 2008-02-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #43766. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.