Model M4735A HeartStart XL Defibrillator//Monitor
FDA device recall Z-1226-03 · posted 2003-09-11 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems
- Reason for recall
- Instructions For Use include addtional information on configuration for selecting Power on Lead
- Action taken
- Philips Medical in conjunction with NNC (National Notification Center) notified users by letter on 9/2/03. Users are provided with Addendum to the HeartStart XL Instructions for Use (to be added to the Instruction for Use) and to familiarize with the configurable Power on Lead. Users are rquested to acknowledge receipt by returning the Business reply Card.
- Root cause
- Other
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 16,736 units
- Distribution
- NATIONWIDE Foreign: Canada, Argentina, Brazil, Chile, Costa Rica, Mexico, Paraguay, Peru, Venezuela, Austalia, China,Hong Kong, India, Japan, Malaysia, Manilla, New Zealand, Manila, Singapore,Taiwan,T
- Date initiated
- 2003-09-02
- Date posted
- 2003-09-11
- Date terminated
- 2005-04-20
- Location
- Andover, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL #M4735A (K021453) | Philips Medical Systems | 2002-07-03 |