Philips Medical Systems Model M4735A HeartStart XL Defibrillator//Monitor Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Model M4735A HeartStart XL Defibrillator//Monitor
Brand
Philips Medical Systems
Lot Codes / Batch Numbers
Units with software versions A.02.00 or greater
Products Sold
Units with software versions A.02.00 or greater
Philips Medical Systems is recalling Model M4735A HeartStart XL Defibrillator//Monitor due to Instructions For Use include addtional information on configuration for selecting Power on Lead. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Instructions For Use include addtional information on configuration for selecting Power on Lead
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026