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 2 Device Recall Philips Lumify Diagnostic Ultrasound

  • 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 2 Device Recall Philips Lumify Diagnostic Ultrasound see related information
Date Initiated by Firm December 09, 2015
Date Posted January 06, 2016
Recall Status1 Terminated 3 on August 08, 2016
Recall Number Z-0596-2016
Recall Event ID 72879
510(K)Number K152899  
Product Classification System, imaging, pulsed doppler, ultrasonic - Product Code IYN
Product Philips Lumify Diagnostic Ultrasound, Catalogue Number: 795216
Part Number: 989605449841 with 453561845331 (software version 1.0)
Code Information System Serial numbers:  USD15L0177; USD15L0178; USD15L0179; USD15L0297; USD15L0298; USN15L0789; USN15L0862; USN15L0863; USN15L0864; USN15L0865; USN15L0866; USN15L0867; USN15L0917; USN15L0918; USN15L0988; USO15L0563; USO15L0564; USO15L0565; USO15L0566; USO15L1087; and USO15L1088. 
Recalling Firm/
Manufacturer		 Philips Ultrasound, Inc.
22100 Bothell Everett Hwy
Bothell WA 98021-8431
For Additional Information Contact Philips Customer Service
800-722-9377
Manufacturer Reason
for Recall		 Color Flow direction is displayed incorrectly in Lumify 1.0. The system displayed Color Flow direction does not correctly represent the annotated Color Bar or Velocity Markers. (e.g.) When the Color Bar conveys that Red is to be displayed for color flow toward the Transducer, the system displays Blue for color flow toward the Transducer. This could result in misdiagnosis in some studies.
FDA Determined
Cause 2		 Software design
Action Philips began mailing the URGENT - Medical Device Correction Philips Model Lumify Ultrasound System, FSN 79500372, dated 2015 DEC 11, to consignees. Consignees are instructed to do the following: 1. Check the version of software on your system using the instructions provided above on How to Identify Affected Products. Philips has corrected this issue in version 1.0.1 and higher. 2. Connect the tablet to the internet. 3. The system will alert you to download the upgrade from Google Play. 4. Follow all on screen to upgrade the software version. If consignees cannot promptly connect to the internet to download the upgraded software, Philips recommends that you do not use Color Flow. In accordance with the subscription terms and conditions, you will be required to reconnect the system to the internet within no more than 30 days. If consignees do not connect their device to the internet after 30 days, they will be unable to use the system. Consignees with questions should contact your local Philips representative or Philips Customer Service at 1-800-722-9377.
Quantity in Commerce 21 units in the US only
Distribution distributed in CA, CT, ND, NV, OR, RI, TN, and WA.
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 = IYN and Original Applicant = PHILIPS HEALTHCARE, INC.
-
-