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U.S. Department of Health and Human Services

Class 2 Device Recall Philips HeartStart

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 Class 2 Device Recall Philips HeartStartsee related information
Date Initiated by FirmJanuary 19, 2010
Date PostedMarch 15, 2010
Recall Status1 Terminated 3 on March 16, 2021
Recall NumberZ-1135-2010
Recall Event ID 54282
510(K)NumberK021453 K031187 
Product Classification internal defibrillator paddles - Product Code MKJ
ProductPhilips Switched Internal Defibrillator Paddles (used with Philips HeartStart XL and HeartStart MRx monitor/defibrillators) used during open heart surgery. Models: M4741A - Extra Large Switched internal Paddles M4742A - Large Switched internal Paddles M4743A - Medium Switched internal Paddles M4744A - Small Switched internal Paddles
Code Information Units with date codes (mmyy) of 0908, 1008, 1108, 1208 (Units manufactured by Philips between September 1, 2008 and December 30, 2008) 
Recalling Firm/
Manufacturer		 Philips Healthcare Inc.
3000 Minuteman Road
Andover MA 01810
For Additional Information ContactSAME
978-687-1501
Manufacturer Reason
for Recall		Paddle shock switch may fail to actuate and delay or prevent delivery of defibrillation therapy
FDA Determined
Cause 2		Nonconforming Material/Component
ActionPhilips issued Urgent Medical Device Recall notification to customers by letter on 1/25/10 via UPS advising of this defect and providing instructions on how to determine if they have a defective paddle. The customers will be assisted by field service engineers to remove and replace these defective units (those within the date range of September 1, 2008 to December 30, 2008). Customers are asked to follow the Actions to be taken by customer/user section of the Urgent Medical Device Recall Notification. Removed units will be replaced free of charge and will be destroyed by Philips. Distribution of the Urgent Medical Device Recall Notification will be managed by Philips representatives in each affected geography. Customers are asked to follow the Actions to be taken by customer/user section of the Urgent Medical Device Recall Notification.
Quantity in Commerce1592 units
DistributionWorldwide distribution: USA, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Dominican Republic, Egypt, Estonia, Finland, France, Georgia, Germany, HONG KONG, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Republic of Korea, Lebanon, Lithuania, Malaysia, Mauritius, Netherlands, NICARAGUA, Norway, Peru, Philippines, POLAND, Portugal, Puerto Rico, Russian Federation, Saudi Arabia, Serbia & Montenegro, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad/Tobago, Turkey, UKRAINE, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, and Vietnam.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = MKJ
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