The Recall Desk
ModerateFDA (Devices)·Z-2409-2025·Announced 2025-09-03

Philips X5-1c Ultrasound Transducer Probe Useful Life Labeling Clarification Recall

Philips Ultrasound is recalling 171,322 X5-1c Transducer Probes distributed nationwide to provide clarification and labeling that defines the useful life of the devices in the field.

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 medical device recall involving labeling clarification about device useful life with no reported incidents or illnesses. This constitutes a voluntary precautionary recall for labeling purposes.

Plain-English summary

Philips Ultrasound, Inc is recalling approximately 171,322 X5-1c Transducer Probes that were distributed nationwide in the United States. The X5-1c Transducer Probe is an ultrasound transducer used in medical ultrasound imaging systems.

The recall is being conducted to provide clarification and labeling that defines the useful life of ultrasound transducers in the field. Healthcare providers and medical facilities should contact Philips Ultrasound, Inc for updated labeling regarding the device's useful life.

Facilities using the X5-1c Transducer Probe should review the manufacturer's updated labeling information concerning the device's useful life and contact Philips Ultrasound for additional information if needed.

The recalled product

Product
X5-1c Transducer Probe
Manufacturer
Philips Ultrasound, Inc
Category
Medical Device — Ultrasound Transducer
Hazard
  • unclear-labeling

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. 989606702251
  • 989605455171
  • 989605400802
  • 989605412042
  • UDI: (01)00884838093843(21)F0B2Q1
  • 010088483809384321F0GQ0H
  • (01)00884838093843(21)F0CD0N
  • (01)00884838093843(21)F0C1LB
  • (01)00884838093843(21)F03QX3
  • (01)00884838093843(21)F04HV1
  • (01)00884838093843(21)F0851Z
  • (01)00884838093843(21)F0BY6P
  • (01)00884838093843(21)F0FJPN
  • (01)00884838093843(21)F0GGZX
  • (01)00884838093843(21)F0JYX2
  • (01)00884838093843(21)F0J1ZT
  • (01)00884838093843(21)F0J3KH
  • (01)00884838093843(21)F0J3MD
  • (01)00884838093843(21)F0J52B
  • (01)00884838093843(21)F0J5TY

Distribution

Distributed nationwide across the United States.

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