Philips S8-3t Ultrasound Transducers Recalled Due to Refurbishment Beyond Useful Life
Philips is recalling 5,230 S8-3t ultrasound transducers because they were refurbished beyond their useful life. The devices were distributed nationwide and internationally to 56 countries.
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 medical device recall. While no injuries or illnesses have been reported, refurbishment of ultrasound transducers beyond their useful life represents a potential risk of device malfunction. As a risk-of-harm medical device product with no reported injury, this meets the criteria for a High severity rating.
Plain-English summary
Philips Ultrasound, Inc. is recalling approximately 5,230 Philips S8-3t ultrasound transducers that were refurbished beyond their useful life. Affected model numbers include 989605420183, 989605431171, 989605439232, and others listed by the FDA.
The recalled transducers were distributed domestically throughout the United States and internationally to approximately 56 countries including Canada, Australia, the United Kingdom, Japan, Germany, China, Brazil, and many others.
Healthcare facilities should verify whether their devices are affected by checking the provided model numbers, UDI codes, and serial numbers against their equipment inventories. Affected users should contact Philips Ultrasound, Inc. for further information and instructions.
The FDA recall number is Z-2061-2025. More information is available through the FDA or directly from Philips Ultrasound, Inc.
The recalled product
- Product
- Philips S8-3t Transducer.
- Manufacturer
- Philips Ultrasound, Inc
- Hazard
- device-malfunction
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. 989605420183
- 989605431171
- 989605439232
- 989605406772
- 989605439231
- 989606708921
- 989803002661
- UDI: (01)00884838073524(21)B2HWZ5
- (01)00884838073524(21)B34PCJ
- (01)00884838073524(21)B34PBW
- (01)00884838073524(21)B37JHN
- (01)00884838073524(21)B34P9K
- (01)00884838073524(21)B2106G
- (01)00884838073524(21)B210DC
- (01)00884838073524(21)B2101L
- (01)00884838073524(21)B2HX89
- (01)00884838073524(21)B2HX1G
- (01)00884838073524(21)B2HX7N
- (01)00884838073524(21)B2HXBB
- (01)00884838073524(21)B2HWZ6
Distribution
Distributed nationwide across the United States.
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