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Physio-Control Initiates Voluntary Suspension of U.S. Shipment of External Defibrillators and Certain Associated Products

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Author: Rob Clark, Public Relations

MINNEAPOLIS – January 16, 2007 – Physio-Control, Inc., a wholly-owned subsidiary of Medtronic, Inc. (NYSE:MDT), announced today that it has voluntarily suspended the U.S. shipment of products manufactured at its facility in Redmond, Wash.  Physio-Control provides external defibrillators and other emergency response products to hospitals, emergency response organizations, and various public and private enterprises.

The decision to suspend U.S. product shipment was made to address quality system issues in Physio-Control’s Redmond facility that were identified by Physio-Control, Medtronic and the U.S. Food and Drug Administration (FDA).  This action is not related to a specific product, does not affect Physio-Control products currently in use worldwide, and does not impact any other Medtronic products.  In addition, Physio-Control will continue to service and repair its installed base of products.  Physio-Control and Medtronic intend to work expeditiously with FDA to address open issues in order to resume shipments to the U.S. market.

“The quality of our products and systems is paramount to Physio-Control and Medtronic,” said Brian Webster, president of Physio-Control.  “This action will allow us to focus necessary resources on remaining issues, which we are confident can be resolved in a timely manner.”

Physio-Control’s action is not expected to have a material effect on Medtronic’s third fiscal quarter ending January 26, 2007.  Any material financial impact or one time charge associated with this action will be disclosed through Medtronic’s customary financial communications and updates.

On December 4, 2006, Medtronic announced its intent to spin-off the Physio-Control business into a separate, publicly-traded company.  Medtronic intends to continue to pursue the spin-off following resolution of these matters.

About Physio-Control
Physio-Control, of Redmond, Wash., pioneered defibrillation technology more than 50 years ago. Today, there are approximately 600,000 LIFEPAK external defibrillator devices distributed worldwide, making the company the leading provider of external defibrillation technology for saving the lives of people suffering sudden cardiac arrest. For more information, visit www.medtronic-ers.com.

About Medtronic
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.
Ratings & Reviews...
On Friday, March 23, 2007, RCEMS513 wrote...
One of the two agencies I work for uses the LP12. The other uses the Zoll E-series. Both agencies are interested in knowing what problems there are in "quality system issues." The fact that Physio has not even begun to describe what the problems are is rather suspect to me.

On Monday, January 22, 2007, mgr22 wrote...
This bulletin strikes me as a superficial press release, lacking details about (1) the nature of the problem; (2) the scope of the problem; (3) risks associated with continued use of these products; and (4) what should be done by customers to avoid problems, if any, with existing units.

At least my patients can be assured that there will be no significant impact on Medtronic's P&L.

On Monday, January 22, 2007, MAJESTIC12 wrote...
So what's the problem?