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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 Recall
Philips Telemonitoring System
see related information
Date Posted October 10, 2008
Recall Status1 Open
Recall Number Z-0100-2009
Recall Event ID 49402
Premarket Notification
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 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.
Code Information M3811B software revision identified as Build 1.1.2.11d, B.02.07.
Recalling Firm/
Manufacturer
Philips Medical Systems
3000 Minuteman Road
Andover, Massachusetts 01810
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact SAME
978-687-1501
Manufacturer Reason
for Recall
Multiprint report may contain incorrect vital data for patients
FDA Determined
Cause 2
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DQA and Original Applicant = PHILIPS MEDICAL SYSTEMS
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