Heartstart HS1 Defibrillator Model M5068A
This recall has been terminated (originally issued March 23, 2010).
- Company
- Philips Medical Systems
- Recall Initiated
- November 2, 2009
- Posted
- March 23, 2010
- Terminated
- May 23, 2013
- Recall Number
- Z-1196-2010
- Quantity
- 34 units distributed domestically
- Firm Location
- Seattle, WA
- Official Source
- View on FDA website ↗
Reason for Recall
Potential for failure of a capacitor during use which would prevent the AED from delivering effective defibrillation therapy when indicated.
Distribution
Worldwide Distribution.
Lot / Code Info
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.
Root 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.