April 27, 2010 / 9:58 PM / 9 years ago

US FDA warns on Cardiac Science devices, shrs fall

* Agency cites faulty external defibrillators

* Some models sold by GE Healthcare

* Cardiac Science shares fall as much as 32 pct (Adds GE comment, updates shares to close)

WASHINGTON, April 27 (Reuters) - U.S. health regulators warned on Tuesday about faulty components in more than a dozen types of external defibrillators made by Cardiac Science Corp CSCX.O, sending its shares down as much as 32 percent.

The agency cited 14 models made by Cardiac Science, some of which are sold by other companies such as General Electric Co’s (GE.N) GE Healthcare unit.

About 280,000 external defibrillators used worldwide to try to rescue people having heart attacks could malfunction, the agency said.

A spokesman for Cardiac Science had no comment.

The FDA said Cardiac Science had already recalled some models, but that other models marketed under GE and Nihon Kohden brands have similar problems. A Cardiac Science software update issued for some models detects some, but not all defects, it added, noting that similar software upgrades are planned for other models.

While users usually check to ensure the device’s green light shows it “is rescue-ready,” that does not mean a faulty device is working and could “give a false sense that they are in proper working order,” the FDA said.

Hospitals, nursing homes and others should use alternative defibrillators, the agency said.

Defibrillators are a key business for the heart device and technology company, and the widespread problems are likely to cost it millions.

Already in 2009, Cardiac Science said it took a $2.5 million voluntary recall charge in the fourth quarter and recorded a charge of $18.5 million for the software update.

GE Healthcare, which distributes Cardiac Science defibrillators under the GE Responder brand, said in a statement that it is working with Cardiac Science to address the concerns cited by the FDA.

Cardiac Science shares closed down nearly 29 percent, or 63 cents, at $1.57 on the Nasdaq after falling as much as 32 percent. (Reporting by Susan Heavey; editing by Andre Grenon and Matthew Lewis)

0 : 0
  • narrow-browser-and-phone
  • medium-browser-and-portrait-tablet
  • landscape-tablet
  • medium-wide-browser
  • wide-browser-and-larger
  • medium-browser-and-landscape-tablet
  • medium-wide-browser-and-larger
  • above-phone
  • portrait-tablet-and-above
  • above-portrait-tablet
  • landscape-tablet-and-above
  • landscape-tablet-and-medium-wide-browser
  • portrait-tablet-and-below
  • landscape-tablet-and-below