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U.S. Department of Health and Human Services

Class 3 Device Recall Philips

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 Class 3 Recall
Philips
see related information
Date Posted September 18, 2008
Recall Status1 Open
Recall Number Z-2369-2008
Recall Event ID 49005
Premarket Notification
510(K) Number
K041674 
Product Classification Oximeter - Product Code DQA
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.
Code Information Software Revision: B.02.07
Recalling Firm/
Manufacturer
Philips Medical Systems
3000 Minuteman Road
Andover, Massachusetts 01810
Manufacturer Reason
for Recall
Software: If Weight Limits edited, values will return to default values that were deleted
FDA Determined
Cause 2
DESIGN: Software Design (Manufacturing Process)
Action Affected customers will receive the Urgent Medical Device Correction notification on 7/22/08 via certified mail. Delivery receipt will be tracked. The Urgent Medical Device Correction notification instructs customers to verify that daily and weekly weight limits are set or not set as intended while they await the correction, which will come in the form of a new version of software and will simultaneously update all systems. Philips has corrected the software defect and is in the process of validating the correction and releasing the corrected software as part of a scheduled release. If further information or support is needed, customers should contact the Telehealth Customer Service Line at 1-866-246-7316.
Quantity in Commerce 49 units
Distribution Nationwide Distribution.
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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