Hispeed Lx//I, Hispeed Fx/I, and Hispeed Dx/I Family of Systems

• • Terminated Z-2224-2009 FDA Unclassified (pre-2012) ·initiated 1 Dec 2008

  During internal testing, GE Healthcare has recently determined that the collimator used on our CT/e and HiSpeed X/i families of Computed Tomography systems does not comply with the specific requirements in United States Title 21 of the Code of Federal Regulations, and IEC 60601-1-3, related to leakage radiation from the diagnostic source assembly, which includes the collimator. The excess leak

• • Terminated Z-0269-05 FDA Unclassified (pre-2012) ·initiated 21 Oct 2004 ·on shared 510(k) K980169

  The patient tables of the affected CT systems are supported by a hydraulic cylinder and a cylinder shaft (i.e. the upper shaft) which connects the tabletop to the table frame. GE received a report of a HiSpeed LX/I system table falling abruptly due to the filure of the upper shaft. No injuries were reported.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K980169 ↗

FDA Product Code

JAK

Device Class

Class II

Regulation

21 CFR Part 892.1750

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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  Class II

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  Class II

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