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Terminated

HeartSine Samaritan AED Defibrillators Models: SAM 001, SAM 002, SAM 003.

FDA Recall Z-1046-05 · Posted 2005-07-28

Recalling FirmHeartsine Technologies Inc
Recall StatusTerminated
Product CodeMKJ
Date Initiated2005-10-05
Date Terminated2012-02-29
Product Quantity1929 units

Reason for Recall

Immediately after battery installation the devices announce a low battery fault warning and shut themselves off, or the service indicator icon starts blinking indicating a fault condition.

Firm Action

AED software revision 1.0.20 and higher incorporate software enhancements to make the AED more forgiving for extreme variations in user technique. Firm will provide distributors with field correction notice dated 10/5/05. Customers to be notified by mid-October 2005.

Root Cause

Device Design

Distribution Pattern

Nationwide, Puerto Rico, Argentina, Australia, Austria, Belgium, Denmark, Ecuador, Finland, France, Germany, Greece, Hong Kong, Iceland, India, Iran, Ireland, Israel, Italy, Japan, Netherlands, Pakistan, Phillipines, Poland, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Thailand, UK

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K023854SAMARITAN AED, MODEL SAM-01Heartsine Technologies, Inc. · 2003-02-14

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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