Cl Ill Philips Telemonitoring System Software

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

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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