Model M4735A HeartStart XL Defibrillator//Monitor
- Company
- Philips Medical Systems
- Recall Initiated
- September 2, 2003
- Posted
- September 11, 2003
- Terminated
- April 20, 2005
- Recall Number
- Z-1226-03
- Quantity
- 16,736 units
- Firm Location
- Andover, MA
Reason for Recall
Instructions For Use include addtional information on configuration for selecting Power on Lead
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,Thailand, Vietnam, ALgeria, Australia,France,Italy, Netherlands,Norway,Oman,Poland, Portugal,South Africa, Spain, Sri Lanka, Sweden, Switzerland, Tunisia, Turkey, UK
Lot / Code Info
Units with software versions A.02.00 or greater
Root Cause
Other
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.