AccessAED Package (without audio record) Model Number: 9100-0150-0
FDA device recall Z-0200-05 · posted 2004-11-20 · Terminated
Recall details
- Recalling firm
- Access CardioSystems
- Reason for recall
- Device may fail to deliver shock due to a faulty circuit board
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 2995 units
- Distribution
- Nationwide Foreign: Spain, Ireland, Chile, Beirut, India, Israel, Singapore
- Date initiated
- 2004-11-03
- Date posted
- 2004-11-20
- Date terminated
- 2006-04-12
- Location
- Concord, MA
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