FDA Medical Device Recalls (openFDA)
Cardiac Science Corporation: Cardiac Science First Save Automated External Defibrillator G3 9300C
- Recall number
- Z-0917-2009
- Recalling firm
- Cardiac Science Corporation
- Product
- Cardiac Science First Save Automated External Defibrillator G3 9300C
- Status
- Terminated
- Initiated
- 2008-10-13
- Posted
- 2009-02-25
- Terminated
- 2011-12-08
- Reason
- Potential for AED to not deliver defibrillation therapy.
- Root cause
- Software design
- Action
- On October 13, 2008 Cardiac Science began sending via Fed-Ex letters and software upgrade kits. Mailing of letters and software upgrade kits is anticipated to be completed by November 21, 2008. The letter instructs consignees to install the software update, assure that the AED information test file generated by the update software is returned to the firm, and complete the postage paid response card and return it to the firm. If the affected devices are no longer in the possession of the consignee, the consignee is to contact the firm and forward the update kit and letter to the person who has the AED in their possession. A separate letter is being sent to distributors. The letter advised to install the software upgrades for any units in stock or to forward the software upgrade along with the end user letter enclosed and that the AED information text file generated by the update software must be returned to the firm. The firm will visit the locations of individual national account customers and install the update. OEM partners will be notified and provided the information and update kits to provide to their customers.
- Quantity
- 2 devices
- Distribution
- Worldwide Distribution: USA, Puerto Rico, Virgin Islands, Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czechoslovakia, Denmark, Dominican Republic, France, Germany, Greece, Guam, Hong Kong, Hungary, Ireland, Israel, Italy, Jamaica, Japan, Kenya, Kuwait, Libya, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, UK, and Ukraine.
- Lot, serial or model codes
- Serial numbers: 332321 and 334948.
- 510(k) numbers
- ["K031987"]
- PMA numbers
- not on file
- Product code
- MKJ
- Firm FEI
- 2112020
- Firm city
- Bothell
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28