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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Heartstart HS1 Home

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  Class 2 Device Recall Philips Heartstart HS1 Home see related information
Date Initiated by Firm April 30, 2010
Date Posted June 28, 2010
Recall Status1 Terminated 3 on December 10, 2012
Recall Number Z-1917-2010
Recall Event ID 55579
510(K)Number K020715  K040904  
Product Classification Automated External Defibrillator - Product Code MKJ
Product Automated External Defibrillator (AED) of brand name "Philips HeartStart HS1 Home" (Model Number M5068A).

Device is designed for use on a person in sudden cardiac arrest who is unresponsive when shaken and not breathing normally
Code Information SERIAL NUMBERS--MODEL M5068A: A10C-05951. 
Recalling Firm/
Manufacturer		 Philips Medical Systems
2301 5th Ave Ste 200
Seattle WA 98121
For Additional Information Contact Dan Donnelly
206-664-5290
Manufacturer Reason
for Recall		 Seventeen AEDs failed production line testing (Final Acceptance Test).
FDA Determined
Cause 2		 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 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.
Quantity in Commerce 1
Distribution Worldwide Distribution -- USA, Canada, Japan, United Arab Emirates, Austria, Switzerland, Germany, Spain, France, Italy, and Norway.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MKJ and Original Applicant = PHILIPS MEDICAL SYSTEMS
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