| Product Description | Model/Product Number | Stock Identifiers | Volume | Recall ID |
| LIFEPAK 500 AED | Noncontiguous Part numbers - 3005400-XXX, D3005400-XXX, U3005400-XXX. | Serial numbers - various | 1,953 devices. | Z-0562-05 |
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AED Recalls
| Alert Details for #2005030227 (Released 3/16/2005 15:09 EST) | |
| Description: | LIFEPAK 500 AED |
|---|---|
| Manufacturer: | Medtronic Emergency Response Systems, Inc., Redmond, WA |
| Reason: | Potential to not detect patients at the low end of the patient impedance range. |
| Analyst Comments: | Confirm receipt of manufacturer's notice dated February 3, 2005. Discontinue use of product and follow manufacturer's instructions for replacement and return. Contact Medtronic: 800.442.1142 or 425.867.4000 or www.medtronic-ers.com/500. |
| Alert Type: | Recall URGENT | Source Alert Type: | FDA Recall Class I |
|---|---|---|---|
| Domain: | Biomedical Devices | Source Type: | FDA Enforcement Report |
| Distribution: | Nationwide and Internationally | Source Date: | 3/16/2005 |
| Product Information |