Recall Z-1196-2010
Philips Medical Systems · initiated November 2, 2009
Product
Heartstart HS1 Defibrillator Model M5068A
Codes / lots: DOMESTIC UNIT SERIAL NUMBERS - A09J-02644, A09J-02180, A09J-02643, A09J-02499, A09J-02169, A09J-02175, A09J-02554, A09J-02645, A09J-01891, A09J-02382, A09J-01903, A09J-02361, A09J-02380, A09J-02033, A09J-02409, A09J-01904, A09J-02351, A09J-02384, A09J-02675, A09J-02625, A09J-02628, A09J-01901, A09J-02360, A09J-02485, A09J-02631, A09J-02642, A09J-02641, A09J-02383, A09J-02647, A09J-02693, A09J-02269, and A09J-02552., A09J-02493, and A09J-01974.
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-1196-2010
- Initiated
- November 2, 2009
- Posted by FDA
- March 23, 2010
- Terminated
- May 23, 2013
- Product code
- NSA – Over-The-Counter Automated External Defibrillator
- Quantity
- 34 units distributed domestically
- Distribution
- Worldwide Distribution.
- Recalling firm
- Philips Medical Systems, Seattle, WA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1193-2010 | Philips Heartstart FRx automated external defibrillator (AED), Model 861304Potential for failure of a capacitor during use which would prevent the AED from delivering effective… | 11/02/2009Terminated |
| 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 |