February 26, 2007 – REDMOND, WA – Physio-Control has issued a statement regarding its voluntary suspension of U.S. shipments LIFEPAK® external defibrillators, which began on January 16th. The action was taken to focus on quality documentation processes, management oversight and internal quality system documentation.
“We take quality assurance issues very seriously and are committed to improving our processes to address the FDA’s concerns and also exceed our own strict internal quality requirements,” said Brian Webster, President.
To download the full text of the statement, click here. For more information, visit http://www.medtronic-ers.com/.