Philips Lumify Diagnostic Ultrasound Recalled for Color Flow Display Error
Philips is recalling 21 Lumify Diagnostic Ultrasound units in the US because a software error displays Color Flow direction incorrectly, which could lead to misdiagnosis.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the source text explicitly states the defect 'could result in misdiagnosis,' which fits the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Philips Ultrasound, Inc. is recalling 21 units of the Philips Lumify Diagnostic Ultrasound (Catalogue Number: 795216, Part Number: 989605449841 with 453561845331, software version 1.0) in the United States. The recall is due to a software defect where the Color Flow direction is displayed incorrectly. Specifically, the system may display the opposite color for flow direction relative to the transducer (e.g., displaying Blue for flow toward the transducer when the Color Bar indicates Red). This discrepancy means the displayed Color Flow direction does not correctly represent the annotated Color Bar or Velocity Markers.
The affected units were distributed in California, Connecticut, North Dakota, Nevada, Oregon, Rhode Island, Tennessee, and Washington. The specific system serial numbers for the 21 affected units are: USD15L0177, USD15L0178, USD15L0179, USD15L0297, USD15L0298, USN15L0789, USN15L0862, USN15L0863, USN15L0864, USN15L0865, USN15L0866, USN15L0867, USN15L0917, USN15L0918, USN15L0988, USO15L0563, USO15L0564, USO15L0565, USO15L0566, USO15L1087, and USO15L1088.
This error could result in misdiagnosis in some studies. Users should contact Philips Ultrasound, Inc. for further instructions on how to resolve the issue.
The recalled product
- Product
- Philips Lumify Diagnostic Ultrasound, Catalogue Number: 795216 Part Number: 989605449841 with 453561845331 (software version 1.0)
- Manufacturer
- Philips Ultrasound, Inc.
- Affected units
- 21
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- System Serial numbers: USD15L0177
- USD15L0178
- USD15L0179
- USD15L0297
- USD15L0298
- USN15L0789
- USN15L0862
- USN15L0863
- USN15L0864
- USN15L0865
- USN15L0866
- USN15L0867
- USN15L0917
- USN15L0918
- USN15L0988
- USO15L0563
- USO15L0564
- USO15L0565
- USO15L0566
- USO15L1087
Distribution
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