16

Feb

2005

Inc. Class II Cardiac Science

0

Company: Cardiac Science, Inc.
Date of Enforcement Report: 2/16/05
Class: II

PRODUCT
a) Powerheart AED G3 Automated External Defibrillator
Model 9300E. Recall # Z-0398-05;
b) Powerheart AED G3 Automated External Defibrillator
Model 9300A (Automatic). Recall # Z-0399-05.

REASON
AEDs may contain an electronic component that does not meet its full operating specifications. The AEDs with this suspect electronic component may not function properly and may interfere with the AED’s ability to delivery therapy. In the event that charge noise is present it will delay the first defibrillation shock in the 3 shock sequence.

CODE
a) All model no. 9300E devices are being recalled
and may contain a serial number as follows:
360814 thru 361239, 361320 thru 362359, 362387
thru 362393, 362396 thru 362713, 362916 thru
364194, 364283 thru 364514, and 364606 thru
364914;
b) All model no. 9300A devices are being recalled
and may contain a serial number as follows:
361240 thru 361317, 362360 thru 362386, 362394,
362715 thru 362914, 364195 thru 364274, 364555
thru 364594, 364915 thru 365294.

RECALLING FIRM/MANUFACTURER
Cardiac Science, Inc., Minnetonka, MN, by telephone on November 12, 2004. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
2,823 units.

DISTRIBUTION
Nationwide and Internationally.

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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