Zoll AED Plus Defibrillator
FDA device recall Z-1206-2009 · posted 2009-04-01 · Terminated
Recall details
- Recalling firm
- ZOLL Medical Corporation, World Wide Headquarters
- Reason for recall
- Device fails to discharge the defibrillation energy.
- Action taken
- On 3/31/09, the firm revised their recall strategy and required all users to a perform a "Mandatory Upgrade" software The software upgrade allows all potentially affected devices to monitor battery charging performance through periodic self-testing. If defective batteries are detected at any time prior to the recommended maximum of five years, users are prompted by the device to install fresh batteries. Frim issued Press Release on April 2, 2009. In the first notification Zoll notified customers by letter on 2/12/09 via certified mail. Customers instructed to replace device batteries every three years. In lieu of replacing batteries every three years, customers will also have the choice to update their devices with software that will monitor batteries for the identified defect. ZOLL will be send email notification to all consignees who have provided an email address as part of their contact information. ZOLL will also be publishing information of the notification on industry magazines. http://www.zollaedplusbatteryhelp.com/
- Root cause
- Process design
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 183,535 units
- Distribution
- Worldwide distribution
- Date initiated
- 2009-02-12
- Date posted
- 2009-04-01
- Date terminated
- 2026-04-09
- Location
- Chelmsford, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ZOLL AED PLUS (K033474) | Zoll Medical Corp | 2004-05-21 |