Recall Z-1916-2010 ยท MKJ Automated External Defibrillators (Non-Wearable)
Philips Medical Systems
Automated External Defibrillator(AED) of brand name "Philips HeartStart HS1 OnSite" (Model number M5066A). Device is designed for use on a person in sudden cardiac arrest who is unresponsive when shaken and not breathing normally
| Date | Jun 28, 2010 (initiated Apr 30, 2010) |
| Status | Terminated |
| Reason | Seventeen AEDs failed production line testing (Final Acceptance Test). |
| Root cause | Nonconforming Material/Component |
| Action | 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 |
| Quantity | 205 |
| Distribution | Worldwide Distribution -- USA, Canada, Japan, United Arab Emirates, Austria, Switzerland, Germany, Spain, France, Italy, and Norway. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020715 | PHILIPS M5066A AND M5068A Philips Medical Systems, Nov 8, 2002 |