Recall Z-1193-2010
Philips Medical Systems · initiated November 2, 2009
Product
Philips Heartstart FRx automated external defibrillator (AED), Model 861304
Codes / lots: DOMESTIC UNIT SERIAL NUMBERS - B09J-00860, B09J-00792, B09J-00810, B09J-00877, B09J-00878, B09J-00793, B09J-01110, B09J-00849, B09J-01016, B09J-01196, B09J-01299, B09J-00855, B09J-00805, B09J-01193, B09J-00896, B09J-00824, B09J-00821, B09J-00823, B09J-00825, B09J-00835, B09J-02749, B09J-00794, B09J-00856, B09J-00889, B09J-00891, B09J-00897, B09J-01005, B09J-01012, B09J-01197, B09J-01230, B09J-01269, B09J-01279, B09J-00791, B09J-00818, B09J-00875, B09J-01082, B09J-01100, B09J-01260, B09J-01010, B09J-01018, B09J-01021, B09J-01022, B09J-01108, B09J-01114, B09J-01120, B09J-01080, B09J-01014, B09J-01298, B09J-01300, B09J-01257, B09J-00872, B09J-00803, B09J-00804, B09J-00868, B09J-01013, B09J-01019, B09J-01020, B09J-01123, B09J-01258, B09J-00786, B09J-00817, B09J-00790, B09J-00816, B09J-01122, B09J-01162, B09J-00789, B09J-00795, B09J-00798, B09J-00806, B09J-00807, B09J-00808, B09J-00842, B09J-00847, B09J-00879, B09J-00892, B09J-01002, B09J-01003, B09J-01006, B09J-01007, B09J-00813, B09J-00819, B09J-00820, B09J-00853, B09J-00884, B09J-01015, B09J-01139, B09J-01252, B09J-01259, B09J-00787, B09J-01253, B09J-01303, and B09J-00898. I INTERNATIONAL UNIT SERIAL NUMBERS - B09J-02902…
Reason for recall
Potential for failure of a capacitor during use which would prevent the AED from delivering effective defibrillation therapy when indicated.
FDA-determined cause: Nonconforming Material/Component
Action taken
The firm notified their US distributors of the recall and instructed them to contact customers and provide information how to return the product to Philips for a free replacement. Firm contacted distributors via phone and email on 11/2/09 and by letter on 11/9/09. A web site providing information related to the recall was activated on 11/3/09.
Details
- Recall number
- Z-1193-2010
- Initiated
- November 2, 2009
- Posted by FDA
- March 23, 2010
- Terminated
- May 23, 2013
- Product code
- MKJ – Automated External Defibrillators (Non-Wearable)
- Quantity
- 92 units distributed domestically, 452 units distributed internationally
- Distribution
- Worldwide Distribution.
- Recalling firm
- Philips Medical Systems, Seattle, WA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1194-2010 | Philips Heartstart (HS1) Onsite Automated External Defibrillator (AED) Catalog number…Potential for failure of a capacitor during use which would prevent the AED from delivering effective… | 11/02/2009Terminated |
| Z-1195-2010 | Heartstart (HS1) Laerdal brand onsite Automated External Defibrillator, Model M5067APotential for failure of a capacitor during use which would prevent the AED from delivering effective… | 11/02/2009Terminated |
| Z-1196-2010 | Heartstart HS1 Defibrillator Model M5068APotential for failure of a capacitor during use which would prevent the AED from delivering effective… | 11/02/2009Terminated |