The Recall Desk
HighFDA (Devices)·Z-2058-2025·Announced 2025-07-09

Philips S5-1 Ultrasound Transducers Refurbished Beyond Useful Life

Philips Ultrasound is recalling Philips S5-1 Transducers because they were refurbished beyond their useful life, which may affect device performance and safety.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall for a medical device where the hazard (refurbishment beyond useful life) creates risk of harm to patients through potential device malfunction. No injuries or illnesses are reported in the source text, placing the score at the maximum of 3 per the rubric criterion for high-risk products where injury has not yet been reported.

Plain-English summary

Philips Ultrasound, Inc. is recalling Philips S5-1 Transducers (Model No. 989605412082, 989605440682, 989605440681, 989803002101) because the devices were refurbished beyond their useful life.

Approximately 5,230 units have been 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, Turkey, United Kingdom, United Arab Emirates, Venezuela, and Vietnam.

Devices refurbished beyond their useful life may not perform as intended and could compromise patient safety. Healthcare providers and patients who have received or are using affected transducers should contact Philips Ultrasound for guidance on device inspection and potential replacement options.

The recalled product

Product
Philips S5-1 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. 989605412082
  • 989605440682
  • 989605440681
  • 989803002101
  • UDI: (01)00884838061637(21)B1FTT9
  • (01)00884838061637(21)B18351
  • (01)00884838061637(21)B1F61P
  • (01)00884838061637(21)B13G8Q
  • (01)00884838061637(21)B1F8HC
  • (01)00884838061637(21)B13G72
  • (01)00884838061637(21)B15D2R
  • (01)00884838061637(21)B0R53Y
  • (01)00884838061637(21)B15CCP
  • (01)00884838061637(21)B194WG
  • (01)00884838061637(21)B0ZZF8
  • (01)00884838061637(21)B15NQ6
  • (01)00884838061637(21)B170FW
  • (01)00884838061637(21)B15P4B
  • (01)00884838061637(21)B0QNTP
  • (01)00884838061637(21)B140K4

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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