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Terminated

Heartsine Samaritan AED Defibrillators - Models: SAM 001, SAM 002, SAM 003. Serial numbers within range of 1270 - 2324 (not all are affected).

FDA Recall Z-0641-05 · Posted 2005-03-23

Recalling FirmHeartsine Technologies Inc
Recall StatusTerminated
Product CodeMKJ
Date Initiated2005-02-14
Date Terminated2011-06-08
Product Quantity672

Reason for Recall

The affected Automatic External Defibrillators (AED) annouce 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.

Firm Action

Recall was initiated by telephone 2/14/2005 with follow-up fax, email or postal mailing using one of several customized letters for distributors or customers. Customers will be sent an upgrade kit by overnite mail and forms to confirm upgrade.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Nationwide to distributors and user facilities. Also to Argentina, Austria, Belgium, Finland, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Kuwait, Netherlands, Portugal, Puerto Rico, Singapore, Spain, Switzerland, Thailand, United Kingdom.

Official Source

View FDA Recall →

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

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