The Recall Desk
LowFDA (Devices)·Z-2374-2025·Announced 2025-09-03

Philips L12-4 Lumify Ultrasound Transducer Probe Labeling Clarification

Philips is recalling approximately 171,322 L12-4 Lumify Transducer Probes distributed nationwide to provide clarification and updated labeling defining the useful life of ultrasound transducers.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: This is a Class III medical device recall involving a documentation and labeling clarification issue. The source text indicates no illnesses or injuries have been reported, and the issue concerns defining useful life through labeling—a documentation matter rather than a product safety hazard.

Plain-English summary

Philips Ultrasound, Inc. is recalling approximately 171,322 units of L12-4 Lumify Transducer Probes distributed nationwide in the United States. The recall is precautionary and relates to labeling clarification regarding the useful life of ultrasound transducers in clinical use.

The company is issuing updated labeling to provide clarification and define the useful life of the transducers. No patient injuries, illnesses, or adverse events have been reported.

The recalled product

Product
L12-4 Lumify Transducer Probe
Manufacturer
Philips Ultrasound, Inc
Category
Medical Device — Ultrasound transducer
Hazard
  • labeling-clarification
  • device-useful-life

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)

  • Model No. 989605434813
  • 989605451171
  • 989605434812
  • 989605477121
  • 989605434811
  • UDI: (01)00884838085169(21)B3GM1J
  • (01)00884838072305(21)B21GN4
  • (01)00884838085169(21)F07MZ5
  • (01)00884838068759(21)B21Z05
  • (01)00884838085169(21)B35YH3
  • (01)00884838085169(21)F0FG0Y
  • (01)00884838086586(21)B2C7QM
  • (01)00884838085169(21)B25WBT
  • (01)00884838085169(21)F01RBW
  • (01)00884838085169(21)F0CJ0M
  • (01)00884838085169(21)F0KW5F
  • (01)00884838085169(21)F00CDB
  • (01)00884838085169(21)F0DC9D
  • (01)00884838085169(21)F0DCLR
  • (01)00884838085169(21)F0DDF7

Distribution

Distributed nationwide across the United States.

Related recalls

Same category