FDA publishes Kodak, Siemens product snags

The Food and Drug Administration this month is reporting that two medical imaging vendors have initiated actions to correct product deficiencies.

Eastman Kodak of Rochester, NY, has initiated a recall of 26 boxes of its oncology x-ray film known as ECFLM. The film was actually graphic arts film that had been slit, chopped and packaged in 35 x 43-cm sheets as oncology film, according to the FDA, which has posted details of the recall at http://www.fda.gov/bbs/topics/ENFORCE/ENF00641.HTML. The film was distributed in California, Missouri, North Carolina, Pennsylvania, Texas, and Wisconsin, according to the FDA.

The agency has also published details of a company-initiated field service effort covering 387 Magnetom 42 SP MRI systems manufactured by Siemens Medical Systems of Iselin, NJ. According to the FDA's enforcement report at http://www.fda.gov/bbs/topics/ENFORCE/ENF00641.html, Siemens is repairing the systems, which misinterpret birth years of 2000 or higher as 1900.

By Auntminnie.com staff writers
May 12, 2000
Copyright © 2000 AuntMinnie.com
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