NEWS
02/24/1994

<TITLE>Siemens Medical Systems Inc. signs consent decree requiring correction of manufacturing problems at several domestic and foreign facilities</TITLE>
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P94-7                              Food and Drug Administration
FOR IMMEDIATE RELEASE              Sharon Snider (301) 443-3285

     The Food and Drug Administration today announced that Siemens
Medical Systems Inc., which makes and imports a variety of medical
devices, has signed a consent decree requiring correction of
manufacturing problems at several domestic and foreign facilities.
     The firm, based in Iselin, N.J., makes patient monitors,
ultrasound equipment, radiation therapy devices, pacemakers,
hearing aids and other medical products.  The firm also imports and
distributes ventilators, pacemakers and ultrasound equipment made
by subsidiaries of its multinational parent company, Siemens
Aktiengesellschaft (Siemens AG), based in Germany.
      "When serious manufacturing violations are found, companies
need to correct them.  These violations can put the public health
at risk," said FDA Commissioner David A. Kessler, M.D. 
     "Manufacturing standards must be followed by all medical
device manufacturers, domestic and foreign.  Foreign companies will
be held to the same exacting standards as U.S. companies," he said.
     FDA inspections in the past year disclosed numerous
manufacturing problems at five domestic and five foreign facilities
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                                         Page 2, P94-7, Siemens
that could affect the quality and safety of Siemens products. 
These include inadequate quality-assurance programs,  inadequate
inspections of finished devices, and inadequate investigation and
handling of complaints.
     In a consent decree of permanent injunction filed today in the
U.S. District Court in New Jersey, Siemens Medical Systems will be
required to stop making and shipping medical devices at three U.S.
facilities for any use in the United States until it corrects the
long-term, recurring manufacturing problems and brings the
facilities into compliance with FDA's Good Manufacturing Practice
(GMP) regulations.  The three facilities--in Concord, Calif.;
Danvers, Mass.; and Issaquah, Wash.--will be closed immediately.
     The company will also be required to correct problems at two
other facilities located in Sylmar, Calif., and Piscataway, N.J.,
hire independent consultants and certify that the facilities comply
with GMP regulations. These facilities will be allowed to remain
open while problems are corrected.
     The consent decree also prohibits the firm from importing and
distributing medical devices made at two Siemens facilities until
manufacturing problems at those facilities and at a related
facility are corrected and the corrections have been verified by
FDA.
     Two other foreign facilities will be required to correct
manufacturing problems, and Siemens Medical Systems will have to
provide certifications to FDA that they comply with GMP 
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                                             Page 3, P94-7, Siemens
regulations.   In addition, within the next 18 months, the firm
will have to provide certifications that all other Siemens foreign
facilities that make and export medical devices to the United
States meet GMP regulations.
     Siemens Medical Systems also operates a nationwide service and
repair network to support its medical products.  The consent decree
requires the company to take steps to ensure that any device-
related problems that it becomes aware of through the network are
properly handled and investigated.
     Other Siemens Medical Systems facilities will be allowed to
remain open.  However, they are all required under a permanent
injunction to comply with manufacturing requirements.
     FDA is one of eight Public Health Service agencies within HHS. 
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