Company: Philips Medical Systems
Date of Enforcement Report 11/5/2008
Class:ll

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, Recall # Z-0100-2009

REASON
Multiprint report may contain incorrect vital data for patients.

RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Andover, MA, by letters on September 11, 2008. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
52 units
DISTRIBUTION
Nationwide