The Recall Desk
ModerateFDA (Devices)·Z-2368-2025·Announced 2025-09-03

Philips D5cwc Ultrasound Transducers Recalled for Labeling Clarification

Philips Ultrasound is recalling 171,322 units of the D5cwc Transducer Probe nationwide to provide labeling clarification and define the product's useful life.

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: FDA Class III classification focused on labeling and documentation clarification regarding useful life. No reported injuries or adverse events documented. The recall is precautionary in nature, addressing labeling improvements to prevent potential misuse beyond intended device lifespan.

Plain-English summary

Philips Ultrasound, Inc. is recalling 171,322 units of the D5cwc Transducer Probe (Models 989605438561 and 989605412062) distributed nationwide in the United States. The recall was issued to provide clarification and labeling to define the useful life of the ultrasound transducers in the field.

Affected consumers who have purchased or are currently using this transducer probe should verify the product information and labeling with Philips Ultrasound to ensure proper understanding of the device's intended useful life. No adverse events or injuries have been reported in connection with this recall.

Consumers with questions regarding this recall should contact Philips Ultrasound, Inc. directly for further information and guidance on the updated labeling and useful life definitions for the D5cwc Transducer Probe.

The recalled product

Product
D5cwc Transducer Probe
Manufacturer
Philips Ultrasound, Inc
Hazard
  • labeling-deficiency
  • useful-life-unclear

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. 989605438561
  • 989605412062
  • UDI: (01)00884838061354(21)B1XLGQ
  • (01)00884838061354(21)B2L6LQ
  • (01)00884838061354(21)B1YGH9
  • (01)00884838061354(21)F0F143
  • (01)00884838061354(21)B1YGN1
  • (01)00884838061354(21)B2Q6W8
  • (01)00884838061354(21)B2L6MM
  • (01)00884838061354(21)B2Q6PV
  • (01)00884838061354(21)B2Q6QF
  • (01)00884838061354(21)F0FYTZ
  • (01)00884838061354(21)F04N02
  • (01)00884838061354(21)B1YGJH
  • (01)00884838061354(21)B1YGJK
  • (01)00884838061354(21)B2L6LH
  • (01)00884838061354(21)B2L6LT
  • (01)00884838061354(21)F0D4X3
  • (01)00884838061354(21)B1N4NC
  • (01)00884838061354(21)B2Q6CZ

Distribution

Distributed nationwide across the United States.