Philips S7-3t Ultrasound Transducers Refurbished Beyond Useful Life
Philips is recalling 5,230 S7-3t ultrasound transducers that were refurbished beyond their useful life. Devices operated beyond their intended operational lifespan may not perform reliably.
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 FDA Class II recall involves medical devices refurbished beyond their useful operational life. While no injuries or illnesses have been reported, ultrasound transducers operated beyond their intended lifespan represent a risk-of-harm medical device where diagnostic performance may be compromised.
Plain-English summary
Philips Ultrasound, Inc. is recalling the S7-3t Transducer due to refurbishment beyond useful operational life. Approximately 5,230 units were distributed domestically throughout the United States and internationally to more than 50 countries.
The FDA classified this as a Class II recall because devices refurbished beyond their useful life may not operate reliably. Ultrasound transducers that have exceeded their intended operational lifespan may no longer meet performance standards.
Affected model numbers are 989605440772, 989605440771, 989605439232, 989605406772, 989605439231, 989606708921, and 989803002661. Corresponding unit identifiers and serial numbers for affected devices are listed in the FDA recall notice.
The recalled product
- Product
- Philips S7-3t Transducer.
- Manufacturer
- Philips Ultrasound, Inc
- Hazard
- device-degradation
- diagnostic-failure
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. 989605440772
- 989605440771
- 989605439232
- 989605406772
- 989605439231
- 989606708921
- 989803002661
- UDI: (01)00884838061439(21)B2103Y
- (01)00884838061439(21)B1J2M7
- (01)00884838061439(21)B2HX4N
- (01)00884838061439(21)B187KZ
- (01)00884838061439(21)B2HXHR
- (01)00884838061439(21)B2104Q
- (01)00884838061439(21)B178YZ
- (01)00884838061439(21)B22VWR
- (01)00884838061439(21)B37JGY
- (01)00884838061439(21)B131BH
- (01)00884838061439(21)B3DVFC
- (01)00884838061439(21)B1BX6R
- (01)00884838061439(21)B3JQF5
Distribution
Distributed nationwide across the United States.
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