FDA Medical Device Recalls (openFDA)
Access CardioSystems: AccessAED PAD Package (without ECG trace) Model Number: 9100-0015-0
- Recall number
- Z-0206-05
- Recalling firm
- Access CardioSystems
- Product
- AccessAED PAD Package (without ECG trace) Model Number: 9100-0015-0
- Status
- Terminated
- Initiated
- 2004-11-03
- Posted
- 2004-11-20
- Terminated
- 2006-04-12
- Reason
- Device may fail to deliver shock due to a faulty circuit board
- Root cause
- Other
- Action
- AccessCardiosystems issued recall letters on 11/3/04 to US Customers by Registered, Certified, Return Receipt requested USPS mail. The foreign mailings made through Federal Express with delivery confirmation.
- Quantity
- 2527 units
- Distribution
- Nationwide Foreign: Spain, Ireland, Chile, Beirut, India, Israel, Singapore
- Lot, serial or model codes
- Serial Numbers: 075180 through 084760
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MKJ
- Firm FEI
- 3003585458
- Firm city
- Concord
- Firm state
- MA
- 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