Philips Switched Internal Defibrillator Paddles (used with Philips HeartStart XL and HeartStart MRx monitor/defibrillato
FDA device recall Z-1135-2010 · posted 2010-03-15 · Terminated
Recall details
- Recalling firm
- Philips Healthcare Inc.
- Reason for recall
- Paddle shock switch may fail to actuate and delay or prevent delivery of defibrillation therapy
- Action taken
- 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. 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 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, Finla
- Date initiated
- 2010-01-19
- Date posted
- 2010-03-15
- Date terminated
- 2021-03-16
- Location
- Andover, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HEARTSTART MRX, MODEL M3535A (K031187) | Philips Medical Systems | 2003-08-27 |
| HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL #M4735A (K021453) | Philips Medical Systems | 2002-07-03 |