—#72508

Product

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.

FDA product code: DQA — Oximeter
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K041674
Affected lot / code info: Software Revision: B.02.07

Why it was recalled

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

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Philips Medical Systems
Address: 3000 Minuteman Road, Andover, Massachusetts 01810

Distribution

Distribution pattern: Nationwide Distribution.

Timeline

Recall initiated: 2008-07-22
Posted by FDA: 2008-09-18
Terminated: 2012-05-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #72508. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.