—#142399

Product

Philips Lumify Diagnostic Ultrasound, Catalogue Number: 795216 Part Number: 989605449841 with 453561845331 (software version 1.0)

FDA product code: IYN — System, Imaging, Pulsed Doppler, Ultrasonic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K152899
Affected lot / code info: 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.

Why it was recalled

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.

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Philips Ultrasound, Inc.
Address: 22100 Bothell Everett Hwy, Bothell, Washington 98021-8431

Distribution

Distribution pattern: distributed in CA, CT, ND, NV, OR, RI, TN, and WA.

Timeline

Recall initiated: 2015-12-09
Posted by FDA: 2016-01-06
Terminated: 2016-08-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #142399. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.