700-F Series Stimulation Electrodes

• 2 recalls, same reason

  • Terminated Z-0462-2015 FDA Class I ·initiated 6 Nov 2014
  • Terminated Z-0461-2015 FDA Class I ·initiated 6 Nov 2014

  Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. The failure to connect may result in a delay of therapy, which could result in patient death or serious injury.

• • Terminated Z-0856-2012 FDA Unclassified (pre-2012) ·initiated 31 Mar 2011 ·on shared 510(k) K964469

  The specific lot was assembled without the rivet cover.

• • Terminated Z-0735-2012 FDA Unclassified (pre-2012) ·initiated 9 Mar 2011

  The product lot was assembled with an R2 Connector, rather than a Zoll Connector.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K964469 ↗

FDA Product Code

LDD

Device Class

Class II

Regulation

21 CFR Part 870.5300

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• 700-MP Disposable Radiolucent Multi-Pad Electrodes

  Class III

  FDA 510(k) K970719 Active Cleared 16 Apr 1997

• 700-SP Series Disposable Stimulation Electrodes

  Class III

  FDA 510(k) K971148 Active Cleared 15 May 1997

• 700-FR Series Radiolucent Stimulation Electrodes

  Class III

  FDA 510(k) K964991 Active Cleared 15 Jan 1997