| Product Description | Model/Product Number | Stock Identifiers | Volume | Recall ID |
| Philips Medical HeartStart MRx Monitor/Defibrillator | Model: M3535A, M3536A | Software Versions A.03.00 or lower and B.04.00 and lower. | 5,125 units total. | Z-0848-05 |
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AED Recalls
| Alert Details for #2005050316 (Released 5/25/2005 18:37 EDT) | |
| Description: | Philips Medical HeartStart MRx Monitor/Defibrillator |
|---|---|
| Manufacturer: | Philips Medical Systems, Andover, MA |
| Reason: | The device may disarm and not deliver shock when performing a Synchronized Cardioversion. |
| Analyst Comments: | Confirm receipt of manufacturer's notice dated May 2, 2005. If this item is in your inventory, please contact the manufacturer, distributor, or your service representative for additional information. Contact Philips: Toll Free (US): (800) 722-7900 Ext. 0 or www.medical.philips.com. |
| Alert Type: | Recall | Source Alert Type: | FDA Class II |
|---|---|---|---|
| Domain: | Biomedical Devices | Source Type: | FDA Enforcement Report |
| Distribution: | Nationwide and Internationally | Source Date: | 5/25/2005 |
| Links: |
|---|
| http://www.fda.gov/po/enforceindex/2005enforce.html |
| Product Information |