Heartstart (HS1) Laerdal brand onsite Automated External Defibrillator, Model M5067A
FDA device recall Z-1195-2010 · posted 2010-03-23 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems
- Reason for recall
- Potential for failure of a capacitor during use which would prevent the AED from delivering effective defibrillation therapy when indicated.
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 1 unit internationally
- Distribution
- Worldwide Distribution.
- Date initiated
- 2009-11-02
- Date posted
- 2010-03-23
- Date terminated
- 2013-05-23
- Location
- Seattle, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PHILIPS M5066A AND M5068A (K020715) | Philips Medical Systems | 2002-11-08 |