Automated External Defibrillator (AED) of brand name "Philips HeartStart FRx" (Model number 861304). Device is designed
FDA device recall Z-1915-2010 · posted 2010-06-28 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems
- Reason for recall
- Seventeen AEDs failed production line testing (Final Acceptance Test).
- Action taken
- The firm notified U.S. distributors on 4/30/2010 via phone call and e-mail to obtain consignee location information. A website providing information was activated on 4/30/2010. On 5/3/2010 Urgent Medical Device Recall letters, dated April 29, 2010 were sent to direct customers in the US. The letters explained the reason for the recall and Customers were asked to verify that they have the product subject to recall. Replacement AEDs will be provided at no charge to the customer. Field Safety Notices were attached to the letters and provided a list of actions for customers to take. Customers should check the serial number on their devices against the list provided, contact Philips Healthcare to arrange for replacement, and ensure that necessary staff are aware of the recall. For further information and support, Philips Healthcare should be contacted at 1-800-263-3342.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 265
- Distribution
- Worldwide Distribution -- USA, Canada, Japan, United Arab Emirates, Austria, Switzerland, Germany, Spain, France, Italy, and Norway.
- Date initiated
- 2010-04-30
- Date posted
- 2010-06-28
- Date terminated
- 2012-12-10
- Location
- Seattle, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PHILIPS HEARTSTART FRX DEFIBRILLATOR, MODEL 861304 (K050004) | Philips Medical Systems | 2005-02-25 |