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Siemens' Ultrasound Group

This article was originally published in The Gray Sheet

Executive Summary

Receives FDA approval Nov. 3 to resume manufacturing and shipping of diagnostic ultrasound systems to U.S. customers from a new facility in Issaquah, Washington. Under a consent decree entered into with the agency in February ("The Gray Sheet" Feb. 28, p. 5), Siemens agreed to cease production and shipments of ultrasound products from a now-closed Issaquah facility due to what FDA called "long-term manufacturing problems." On Nov. 2, the firm received FDA approval to resume production and shipping from its Concord, California-based Oncology Care Systems Group, which also was subject to the consent decree. A third facility covered by the consent decree, located in Danvers, Massachusetts, remains under suspension, and no timetable for its reinspection has been decided, according to Siemens
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