| Product Description | Model/Product Number | Stock Identifiers | Volume | Recall ID |
| life+cel, Replacement Battery for Cardiac Science Powerheart AED G3, Lithium Sulfur Dioxide, voltage 12V, 7.5 amps | OEM P/N: 9146-001; Part #: 7L877 | All Replacement batteries. Distributed primarily to Police/Fire Departments. | 24 units total. | Z-0523-2008 |
| life+cel, Replacement battery for Cardiac Science FirstSave SurvivaLink, Lithium Sulfur Dioxide, Voltage 12V, 7.5 Amps | OEM P/N: 9141-001; Part #: 2L561 | All Batteries. | 118 units total. | Z-0524-2008 |
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AED Recalls
| Alert Details for #2007120813 (Released 12/28/2007 15:06 EST) | |
| Description: | Update to RASMAS Alert #2007120715 of 12/21/07 (Additional Product Descriptions and Model/Product Numbers specified) life+cel, Replacement Batteries for Cardiac Science: Powerheart AED and FirstSave SurvivaLink |
|---|---|
| Manufacturer: | Manufacturer: Nordix, Inc.; Manufactured for: BatteryZone, Inc., Somerset, NJ; Cardiac Science Corporation, Bothell, WA; Phoenix Solutions, Clifton Park, NY |
| Reason: | Marketed without 510 (K) approval. |
| Analyst Comments: | Please click on the attachment in the Links field to view notification details, dated August 24, 2007. The original recall communication (important recall information) was sent out on 9/3/07 by Phoenix Solutions, a consultant to BatteryZone. A second recall communication, Urgent Device Recall, was issued by BatteryZone dated 10/25, and was sent out to all customers (even those who had returned product) on 11/5/07. Both communications were sent by first class mail. Contact BatteryZone Customer Service at Tel: 732-652-5270. Contact Cardiac Science at Tel: 800-426-0337, or Tel: 425-402-2000. Contact Phoenix Solutions at Tel: (518) 383-9897, Fax: (518) 383-9897, or E-Mail: info@PhoenixSolutions.com. |
| Alert Type: | Recall | Source Alert Type: | FDA Recall Class II |
|---|---|---|---|
| Domain: | Biomedical Devices | Source Type: | Food and Drug Administration |
| Distribution: | United States | Source Date: | 12/28/2007 |
| Links: |
|---|
| Battery Information on BatteryZone Website - http://www.batteryzone.com/medical.tpl AED Information on Cardiac Science Website - http://www.powerheart.com/products/index.htm Cardiac Science Website - http://www.cardiacscience.com Phoenix Solutions Website - http://www.phoenixsolutions.com FDA CDRH Notification (PDF) - AED2007120813.pdf |
| Product Information |