Philips Medical Systems M3811B Philips Telemonitoring Clinical Review Software part of Philips Telemonitoring System, M3810A, software revision identified as Build 1.1.2.11d, B.02.07. Prescriptive medical device used to automatically collect and transmit medical information (weight, blood pressure, non-diagnostic ECG) over phone lines between provider and patient. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
M3811B Philips Telemonitoring Clinical Review Software part of Philips Telemonitoring System, M3810A, software revision identified as Build 1.1.2.11d, B.02.07. Prescriptive medical device used to automatically collect and transmit medical information (weight, blood pressure, non-diagnostic ECG) over phone lines between provider and patient.
Brand
Philips Medical Systems
Lot Codes / Batch Numbers
M3811B software revision identified as Build 1.1.2.11d, B.02.07.
Products Sold
M3811B software revision identified as Build 1.1.2.11d, B.02.07.
Philips Medical Systems is recalling M3811B Philips Telemonitoring Clinical Review Software part of Philips Telemonitoring System, M3810A due to Multiprint report may contain incorrect vital data for patients. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Multiprint report may contain incorrect vital data for patients
Recommended Action
Per FDA guidance
Philips contacted customers by sending an Urgent Medical Device Correction Notification on 9/11/08. Letters to customers sent via certified mail and receipt of delivery will be tracked. Customers are asked to follow the Action To Be Taken By Customer/User section of the Urgent Medical Device Correction Notification. This section instructs users to allow the upgrade of the software upon logging in to the system. Contact Philips at 1-866-246-7316 for assistance.
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