Siemens Medical Systems has agreed to stop production at three of its seven U.S. manufacturing plants until it corrects quality-control problems at those facilities.
Under the consent decree with the Food and Drug Administration, the company also will fix manufacturing problems at two other U.S. plants while they continue operations and stop importing or distributing goods made at two facilities abroad.
The Iselin, N.J.-based company and its parent, Siemens AG of Germany, make pacemakers, patient monitors, ultrasound equipment and other medical products. Products affected by the decree represent 8% of its $1.8 billion in U.S. sales, a spokesman said.
"We expect there will be no disruption in our customers' ability to deliver patient healthcare," its president said in a statement. "The issues cited by the FDA involve primarily procedural and recordkeeping issues."