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The Medical Industry
Business Weekly
May 15, 2008

Other Headlines

Leon Gugel, the company's DOTmed Certified founder, pitches honesty, integrity and outstanding service.
Due to provider requests, KLAS investigated single-cassette computed radiography (CR) in a groundbreaking study to uncover the strengths and weaknesses of the marketplace.
The SNM Annual Meeting runs June 14-18 in New Orleans. Be sure to come by the DOTmed Booth #570 and meet our jazzy Trade Show Team!
Earthquakes, typhoons, cyclones, tornadoes and more lead to death and disaster across the globe.

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More Industry Headlines

Hospitals Demand Feedback About Computed Radiography Due to provider requests, KLAS investigated single-cassette computed radiography (CR) in a groundbreaking study to uncover the strengths and weaknesses of the marketplace.

Worldwide Weather Woes Bring Disaster and Grief Earthquakes, typhoons, cyclones, tornadoes and more lead to death and disaster across the globe.

Strike Force Targets Medicare Fraud by Los Angeles Area Health Care Companies Eleven people indicted in case involving millions of dollars in claims.

House Subcommittee Hears Testimony on Medicare Bidding Program for Durable Medical Equipment House hears testimony on benefits and drawbacks of Competitive Bidding Program planned for implementation this year.

Medicare Roundup: CMS Recent Decisions Agency gives coverage to artificial hearts, raises rates for long-term care hospitals.

This SIEMENS Open Viva MRI Scanner is going to move fast... get your bid in now! Also see the other great lasers, imaging systems, and more... all on your favorite website for used medical equipment!

Are Anxiety Disorders All in the Mind? Researchers find link between altered dopamine activity and Social Anxiety Disorder, according to an article in the Journal of Nuclear Medicine.

GE's Industry Leading Service Delivers Improved Uptime and Reliability Proactive monitoring and data mining combine to enhance installed base performance.

Philips to Acquire Brazilian Patient Monitoring and Critical Care Company Dixtal Biomedica e Tecnologia Move further bolsters Philips' healthcare presence in high-growth emerging markets.

Smart, Miniature Pump Offers Medicine in Small and Flexible Doses An innovative micro-pump mimics our own peristaltic system, but works accurately forward and backward.

Philips Medical Systems

FDA Warns Philips Medical Systems Regarding Manufacturing Procedures at Ohio Plant

by Joan Trombetti, Writer
U.S. health regulators warned Philips Medical Systems, Inc. of a number of problems with manufacturing procedures at an Ohio plant. The problems included a failure to oversee proper device design. This is according to a letter released on April 22.

FDA inspectors visited Philips' Cleveland plant in September and October 2007. At that time, they discovered more than a dozen production problems at the facility that manufactures computed tomography (CT) and nuclear medicine devices.

Other findings included an inadequate system to manage production changes and problems with software to check devices, the FDA said in an April 1, 2008 letter to Philips Medical Systems, a unit of Philips Electronics NV. The letter also said the company did not properly maintain certain investigative records and failed to set up proper procedures to handle complaints.

Since the inspection, Philips Medical has taken some steps to correct the problems but has not addressed all of them, the FDA said.

According to spokesman Arent Jan Hesselink, the company has resolved 10 of the 14 FDA complaints.

He said the company is working on the remaining four and it is a "matter of implementing some changes, in some cases simply a matter of providing the FDA with documentation."

Read FDA warning letters at
http://www.fda.gov/foi/warning.htm


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