Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 3 Device Recall Philips

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 3 Device Recall Philips see related information
Date Initiated by Firm July 22, 2008
Date Posted September 18, 2008
Recall Status1 Terminated 3 on May 16, 2012
Recall Number Z-2369-2008
Recall Event ID 49005
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 MA 01810
For Additional Information Contact
978-687-1501
Manufacturer Reason
for Recall		 Software: If Weight Limits edited, values will return to default values that were deleted
FDA Determined
Cause 2		 Software design
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 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
-
-