Automated External Defibrillator (non-wearable). Model number 9200, 9200N, 9200DN, 9200RD, 9210N, 9210RD, and CardioVive

FDA device recall Z-2917-2011 · posted 2011-08-03 · Terminated

Recall details

Recalling firm

Cardiac Science Corporation

Reason for recall

Cardiac Science Corporation (CSC) intent to end service support and discontinue accessory sales of Powerheart G2 Automated External Defibrillators. Customers are recommended to choose a replacement AED prior to the current AED displaying any "Service Required" self test messages.

Action taken

Cardiac Science Corporation (CSC) sent two "9200 SERIES CARDIAC SCIENCE AED NOTICE" letters dated August 2010 and March 2011 to all affected customers. The letters identifies the product, problem, and actions to be taken by the customers. Customers are encouraged to upgrade their devices through special offers by calling CSC at 800-426-0337, Option 2. For questions about the end of factory support for the affected devices, call the Technical Support team at 800-426-0337, Option 1. *****In August 2011, Cardiac Science sent out another updated recall notification letter to their consignees. This letter stated that once a device has entered the "Service Required" state, please contact the firm at 800.426.0337 Option 2. Per prior notifications, the 9200 series AEDs have reached the end of service life and can no longer be repaired. Information about these notifications may be found as an announcement in the Services and Support section of Cardiac Science website. Cardiac Science advised the customers to upgrade to a Powerheart AED G3 (this device supports the 2010 AHA/ERC Guidelines). It is strongly recommended that customer to choose a replacement AED prior to the current AED displaying any "Service Required" self test messages. For information about special offers to help you upgrade please call 800.426.0337. Option 2.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

MKJ

Quantity affected

48,700 units (41396 units in US; 7304 units Internationally)

Distribution

Worldwide Distribution-USA (nationwide) and the countries of AE, AT, AU, AW, BE, BR, CA, CH, CL, CN, CO, CY, CZ, DE, OK, EG, ES, FI, FR, GB, HK, HR, HU, 10, IE, IL, IN, IR, IS, IT, JP, KR, KW, KY, LB,

Date initiated

2011-06-29

Date posted

2011-08-03

Date terminated

2011-12-20

Location

Bothell, WA

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