—#95579

Product

GE Healthcare Discovery RX (16 slice) PET/CT System; Discovery RX (16 Slice) PET/CT Systems with technical Reference Manual numbers 2351785-xxx and 2390935-xxx distributed from November 2001 to August 2010. Head and whole body X-ray computed tomography applications.

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
Affected lot / code info: Technical Reference Manual numbers 2351785-xxx and 2390935-xxx.

Why it was recalled

Although the system x-ray output is accurate for the technique factors given, and the dose display is also accurate, certain CTDI adjustment factors used for the manual calculation from the Technical Reference Manual (TRM) are incorrect. CTDI100 Aperture Adjustment Factors for 4x0.625 mode contain incorrect values. This issue may lead to inaccurate CTDI manual calculation. The results of the diffe

Root cause (FDA determination)

Radiation Control for Health and Safety Act

Action the firm took

An Important Electronic Product Radiation Warning letter will be provided together with the TRM addendum informing the customers of the issue and related hazards. The letter also identified the affected product and gave instructions, which include referring to the TRM addendum, along with the product correction. This correction will be executed via a Field Modification Instruction IFMI 254281 released in November, 2010 with an estimated completion date of May, 2011. Questions or concerns should be directed to the call numbers listed or a local GE Healthcare Service Representative for countries not listed.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution

Timeline

Recall initiated: 2010-10-27
Posted by FDA: 2011-02-07
Terminated: 2012-07-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #95579. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.