FDA Issues Class I Recall for Select HeartSine Public-Access Defibrillators

FDA has issued a class I recall for certain HeartSine Samaritan public access defibrillators, according to a recall notice.

Advertisement

 

Certain Samaritan 300/300P PAD devices have been found to intermittently turn on and off, which may eventually deplete the battery. In addition and separately, certain Samaritan 300/300P PAD devices containing early versions of the battery management software may misinterpret a temporary drop in battery voltage as signaling a low battery, resulting in the device turning itself off. A device experiencing either condition could be unable to deliver therapy during a cardiac event.

 

Samaritan 300/300P PAD devices with the following serial numbers are affected by this recall:

  • 0400000501 to 0700032917
  • 08A00035000 to 10A0070753
  • 10C00200000 to 10C00210106

 

Related Articles on Recalls:

Mindray Anesthesia Delivery System Voluntarily Recalled

ASP Recalls All Lots of Sterrad Cyclesure 24 Biological Indicators

Baxter Buretrol Solution Sets Recalled

At the Becker's 23rd Annual Spine, Orthopedic and Pain Management-Driven ASC + The Future of Spine Conference, taking place June 11-13 in Chicago, spine surgeons, orthopedic leaders and ASC executives will come together to explore minimally invasive techniques, ASC growth strategies and innovations shaping the future of outpatient spine care. Apply for complimentary registration now.

Advertisement

Next Up in Uncategorized

Advertisement

Comments are closed.