Heartstart (HS1) Laerdal brand onsite Automated External Defibrillator, Model M5067A
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-1195-2010
- Quantity
- 1 unit internationally
- 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
Serial number A09J-02205
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.
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