| Product Description | Model/Product Number | Stock Identifiers | Volume | Recall ID |
| (a) Philips HeartStart MRx Monitor/Defibrillator. | Model: M3535A (Hospital Use) | (a) Software versions A.02.00 and lower | 2,520 units | Z-0341-05 |
| (b) Philips HeartStart MRx Monitor/Defibrillator. | Model No. M3536A (EMS Use) | (b) Software versions A.02.00 and lower | 2,520 units | Z-0341-05 |
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AED Recalls
| Alert Details for #2005010212 (Released 1/12/2005 12:38 EST) | |
| Description: | Philips HeartStart MRx Monitor/Defibrillator |
|---|---|
| Manufacturer: | Philips Medical Systems, Andover, MA |
| Reason: | In Software versions below A.02.00, with the sync function enabled and the device switched from manual to AED, there may be an unexpected delay in delivery of energy. |
| Analyst Comments: | Confirm receipt of manufacturer's notice dated December 13, 2004. Discontinue use of product and follow manufacturer's instructions for replacement and return. Contact: Phone: 978.659.3467 Fax: 978.685.5372, Company Website: www.medical.philips.com. |
| Alert Type: | Recall | Source Alert Type: | FDA Recall Class II |
|---|---|---|---|
| Domain: | Biomedical Devices | Source Type: | FDA Enforcement Report |
| Distribution: | Nationwide and Internationally | Source Date: | 1/12/2005 |
| Links: |
|---|
| http://www.fda.gov/po/enforceindex/2004enforce.html |
| Product Information |