Company: Heartsine Technologies, Inc
Date of Enforcement Report: 3/30/05
Class: I
PRODUCT
Heartsine Samaritan AED Defibrillators — Models: SAM 001, SAM 002,SAM 003. Recall # Z-0641-05.
REASON
The affected Automatic External Defibrillators (AED) announce a fault warning and shut themselves off before a shock can be delivered to the patient. This is reportedly due to slow capacitor charging rates which are interpreted by the AED software as a fault condition.
CODE
Serial numbers within range of 1270 — 2324 (not all are affected).
RECALLING FIRM/MANUFACTURER
Heartsine Technologies, Inc., San Clemente, CA, by telephone and letters on February 14, 2005. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
672 units.
DISTRIBUTION
Nationwide and Internationally.
