Philips Medical Systems Philips Telemonitoring System Software (M3811B) used with Philips Telemonitoring System (M3810B) Revision: 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)

Reason for Recall

As stated by FDA

Software: If Weight Limits edited, values will return to default values that were deleted

Recommended Action

Per FDA guidance

Affected customers will receive the Urgent Medical Device Correction notification on 7/22/08 via certified mail. Delivery receipt will be tracked. The Urgent Medical Device Correction notification instructs customers to verify that daily and weekly weight limits are set or not set as intended while they await the correction, which will come in the form of a new version of software and will simultaneously update all systems. Philips has corrected the software defect and is in the process of validating the correction and releasing the corrected software as part of a scheduled release. If further information or support is needed, customers should contact the Telehealth Customer Service Line at 1-866-246-7316.