Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

GE Healthcare Discovery LS (16 slice) System; Discovery LS (16 Slice) 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 Recall Z-0946-2011 · Posted 2011-02-07

Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeJAK
Date Initiated2010-10-27
Date Terminated2012-07-13
Product Quantity1450 units total in US

Reason for Recall

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

Firm Action

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.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

Worldwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑