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In Brief: Isocam II safety update

This article was originally published in The Gray Sheet

Executive Summary

Isocam II safety update: Preliminary failure analysis by the U.K. Medical Devices Agency (MDA) and Park Medical Systems U.K. Ltd determines that the Isocam II dual-headed nuclear medicine gamma camera is "unsafe for clinical use and will require engineering modifications to render it safe." In light of this, FDA "recommends the immediate removal of the Isocam II from service until further notice," since the manufacturer, Park Medical Systems of Quebec, is no longer in business and Park U.K. does not do business in the U.S. FDA issued a safety alert on the Isocam II on Feb. 13 when MDA reported an incident where a "stainless steel plate from a harmonic drive motor failed, causing an arm of the system to fall into the gantry housing of the device" ("The Gray Sheet" Feb. 23, p. 22)...
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