FDA recalls Philips L9-3 ultrasound transducers refurbished beyond useful life
Philips Ultrasound is recalling approximately 5,230 L9-3 transducer units that were refurbished beyond their useful life, potentially affecting device reliability and performance.
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: FDA Class II medical device recall for devices refurbished beyond their useful life, which may compromise device performance and reliability. No illnesses or injuries reported, but qualifies as a risk-of-harm product where potential injury has not yet been reported.
Plain-English summary
Philips Ultrasound, Inc. is recalling approximately 5,230 L9-3 Transducer units that were refurbished beyond their useful life. The affected devices have model numbers 989605353301, 989605353303, or 989605387361.
The devices have been distributed domestically throughout the United States and internationally to over 50 countries including Canada, Australia, the United Kingdom, Japan, and others. Healthcare facilities should identify affected units by model and serial number.
Healthcare facilities and providers who suspect they have affected devices should stop using them and contact Philips Ultrasound, Inc. for instructions on device replacement, repair, or other remedial actions.
The recalled product
- Product
- Philips L9-3 Transducer.
- Manufacturer
- Philips Ultrasound, Inc
- Hazard
- device-malfunction
- reliability-issue
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. 989605353301
- 989605353303
- 989605387361
- UDI: N/A
- Serial No. B0ZTD1
- 03F40C
- 03923H
- 0314BQ
- 03712H
- 033HGC
- 03CJ9M
- 035JY0
- 03CFTH
- 0399XP
- 030FNL
- 037R81
- 02ZH61
- 0358PF
- 033JGV
- 03FN82
Distribution
Distributed nationwide across the United States.
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