Company: Philips Medical Systems
Date of Enforcement Report 10/29/2008
Class:lll

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, Recall # Z-2369-2008

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

RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Andover, MA, by letter on July 22, 2008. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
49 units

DISTRIBUTION
Nationwide a