Heartsine Samaritan AED Defibrillators - Models: SAM 001, SAM 002, SAM 003. Serial numbers within range of 1270 - 2324 (

FDA device recall Z-0641-05 · posted 2005-03-23 · Terminated

Recall details

Recalling firm

Heartsine Technologies Inc

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.

Action taken

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

Status

Terminated

Product code

MKJ

Quantity affected

672

Distribution

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, Sin

Date initiated

2005-02-14

Date posted

2005-03-23

Date terminated

2011-06-08

Location

San Clemente, CA