Recall Z-1135-2010 ยท MKJ Automated External Defibrillators (Non-Wearable)
Philips Healthcare Inc.
Philips 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
| Date | Mar 15, 2010 (initiated Jan 19, 2010) |
| Status | Terminated |
| Reason | Paddle shock switch may fail to actuate and delay or prevent delivery of defibrillation therapy |
| Root cause | Nonconforming Material/Component |
| Action | Philips 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. Distrib |
| Quantity | 1592 units |
| Distribution | Worldwide 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, Irelan |
| FDA record | Open on fda.gov |