The Recall Desk
ModerateFDA (Devices)·Z-2055-2025·Announced 2025-07-09

Philips L12-4 Ultrasound Transducers Refurbished Beyond Useful Life

Philips Ultrasound, Inc. is recalling 5,230 Philips L12-4 ultrasound transducer devices that were refurbished beyond their useful life. Affected units were distributed domestically and to numerous countries worldwide.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is a Class II medical device recall as classified by the FDA. The source text provides only that the transducers were "refurbished beyond their useful life" with no reported illnesses, injuries, or deaths. The hazard is potential degradation of device function but no adverse health events are stated, making this a voluntary precautionary recall.

Plain-English summary

Philips Ultrasound, Inc. is recalling Philips L12-4 Transducer devices (Model Nos. 989605427122, 989605451171, 989605434813, 989605434812, 989605477121, 989605434811) because the ultrasound transducers were refurbished beyond their useful life. A total of 5,230 units have been affected by this recall.

The recalled units were distributed nationwide in the United States and internationally to Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, New Caledonia, New Zealand, Nicaragua, Oman, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Türkiye, United Kingdom, United Arab Emirates, Venezuela, and Vietnam.

Consumers and healthcare facilities in possession of affected Philips L12-4 transducers should stop using the devices and contact Philips Ultrasound, Inc. for further guidance regarding the recall and appropriate next steps for handling the affected units.

The recalled product

Product
Philips L12-4 Transducer.
Manufacturer
Philips Ultrasound, Inc
Category
Medical Device — Ultrasound Transducer
Hazard
Affected units
5,230

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. 989605427122
  • 989605451171
  • 989605434813
  • 989605434812
  • 989605477121
  • 989605434811
  • UDI: (01)00884838072305(21)B1QJ17
  • (01)00884838061644(21)B2BBRN
  • (01)00884838061644(21)B1GL69
  • (01)00884838072305(21)B1YHN7
  • (01)00884838061644(21)B186QV
  • (01)00884838072305(21)B1QJ0G
  • (01)00884838072305(21)B21GPF
  • (01)00884838072305(21)B1QJ27
  • (01)00884838072305(21)B1QJ0V
  • (01)00884838061644(21)B14YT4
  • 010088483808516921B1L72F
  • (01)00884838072305(21)B21GNP
  • (01)00884838072305(21)B21GNR
  • (01)00884838072305(21)B1YHPV

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 21 recalled by Philips Ultrasound, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 21 products in this recall →

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Same hazard · device degradation

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