Philips Lumify Diagnostic Ultrasound recall
Philips Lumify Diagnostic Ultrasound, Catalogue Number: 795216 Part Number: 989605449841 with 453561845331 (software version 1.0)
Why was Philips Lumify Diagnostic Ultrasound 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- Philips Lumify Diagnostic Ultrasound, Catalogue Number: 795216 Part Number: 989605449841 with 453561845331 (software version 1.0)
- Recalling firm
- Philips Ultrasound, Inc.
- Quantity
- 21 units in the US only
- Distribution
- distributed in CA, CT, ND, NV, OR, RI, TN, and WA.
- Recall date
- January 13, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)