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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Telemonitoring System

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  Class 2 Device Recall Philips Telemonitoring System see related information
Date Initiated by Firm September 11, 2008
Date Posted October 10, 2008
Recall Status1 Terminated 3 on February 06, 2017
Recall Number Z-0100-2009
Recall Event ID 49402
510(K)Number K041674  
Product Classification Oximeter - Product Code DQA
Product M3811B Philips Telemonitoring Clinical Review Software part of Philips Telemonitoring System, M3810A, software revision identified as Build, 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.
Code Information M3811B software revision identified as Build, B.02.07.
Recalling Firm/
Philips Medical Systems
3000 Minuteman Road
Andover MA 01810
For Additional Information Contact SAME
Manufacturer Reason
for Recall
Multiprint report may contain incorrect vital data for patients
FDA Determined
Cause 2
Software design
Action Philips contacted customers by sending an Urgent Medical Device Correction Notification on 9/11/08. Letters to customers sent via certified mail and receipt of delivery will be tracked. Customers are asked to follow the Action To Be Taken By Customer/User section of the Urgent Medical Device Correction Notification. This section instructs users to allow the upgrade of the software upon logging in to the system. Contact Philips at 1-866-246-7316 for assistance.
Quantity in Commerce 52 units
Distribution Nationwide
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DQA and Original Applicant = PHILIPS MEDICAL SYSTEMS