Z-0596-2016Class II

Philips Lumify Diagnostic Ultrasound, Catalogue Number: 795216 Part Number: 989605449841 with 453561845331...

Name: Z-0596-2016 Philips Lumify Diagnostic Ultrasound, Catalogue Number: 795216 Part Number: 989605449841 with 453561845331...
Creator: Philips Ultrasound, Inc.
Published: 2015-12-09
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2015-12-09 / Terminated / root cause: software

FDA source

Philips Ultrasound, Inc. began a recall of Philips Lumify Diagnostic Ultrasound, Catalogue Number: 795216 Part Number: 989605449841 with 453561845331 (software version 1.0) on 2015-12-09. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0596-2016
Classification: Class II
Status: Terminated
Initiated: 2015-12-09
Posted: 2016-01-06
Terminated: 2016-08-08
Recalling firm: Philips North America LLC
Product: Philips Lumify Diagnostic Ultrasound, Catalogue Number: 795216 Part Number: 989605449841 with 453561845331 (software version 1.0)
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
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.
Root cause tag: software
FDA 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 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0596-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0596-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-13	2016-01-06

Product code IYN

K152899Class IIPhilips Lumify Diagnostic Ultrasound SystemPhilips Healthcare, Inc. / cleared 2015-10-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)