Recall Z-0596-2016 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Philips Ultrasound, Inc.
Philips Lumify Diagnostic Ultrasound, Catalogue Number: 795216 Part Number: 989605449841 with 453561845331 (software version 1.0)
| Date | Jan 6, 2016 (initiated Dec 9, 2015) |
| Status | Terminated |
| Reason | 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 | 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 |
| Quantity | 21 units in the US only |
| Distribution | distributed in CA, CT, ND, NV, OR, RI, TN, and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152899 | Philips Lumify Diagnostic Ultrasound System Philips Healthcare, Inc., Oct 30, 2015 |