Philips Medical Systems Philips Medical HeartStartXL Defibrillator/Monitor Model : M4735A Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Philips Medical HeartStartXL Defibrillator/Monitor Model : M4735A
Brand
Philips Medical Systems
Lot Codes / Batch Numbers
Serial Numbers: US00453441 through US00453910
Products Sold
Serial Numbers: US00453441 through US00453910
Philips Medical Systems is recalling Philips Medical HeartStartXL Defibrillator/Monitor Model : M4735A due to The ECG signal may become unusable to assess patient condition and need for therapy.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The ECG signal may become unusable to assess patient condition and need for therapy.
Recommended Action
Per FDA guidance
Philips Medical contacted accounts by letter dated June 11, 2007. Users are advised to remove product from service, if possible. If not, a back up unit should be available to use. Service reps will contact accounts to replace units.
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