Philips L8-4 Ultrasound Transducers Recalled for Refurbishment Beyond Useful Life
Philips Ultrasound is recalling 5,230 L8-4 transducer units that were refurbished beyond their useful life, which may affect device safety and performance. The units were distributed nationwide and internationally.
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: This is an FDA Class II recall. The source states the devices were refurbished beyond their useful life, which is a quality/durability issue rather than a known safety hazard with reported injuries or illnesses. No adverse events are reported in the source text.
Plain-English summary
Philips Ultrasound, Inc. is recalling the Philips L8-4 Transducer (Model Nos. 989605440811, 989605440812). According to the FDA, the devices were refurbished beyond their useful life.
Approximately 5,230 units were affected by this recall. The devices were distributed domestically nationwide and internationally to countries including Australia, Canada, China, France, Germany, India, Japan, Mexico, South Korea, the United Kingdom, and others.
Users of affected transducers should contact Philips Ultrasound, Inc. for instructions on return or replacement. Additional information is available from the FDA's Medical Device Recalls database at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=Z-2056-2025.
The recalled product
- Product
- Philips L8-4 Transducer.
- Manufacturer
- Philips Ultrasound, Inc
- 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. 989605440811
- 989605440812
- UDI: (01)00884838067684(21)B0LZNN
- (01)00884838067684(21)03BPVM
- (01)00884838067684(21)02KMFZ
- (01)00884838067684(21)02HJDK
- (01)00884838067684(21)02FWNQ
- (01)00884838067684(21)02KKZT
- (01)00884838067684(21)03H7GL
- (01)00884838067684(21)02LTKK
- (01)00884838067684(21)02H2JM
- (01)00884838067684(21)02KKVB
- (01)00884838067684(21)038XYV
- (01)00884838067684(21)02DLVR
- (01)00884838067684(21)02CCM5
- (01)00884838067684(21)02LT6G
- (01)00884838067684(21)02KMKK
- (01)00884838067684(21)02V8VD
- (01)00884838067684(21)037Z2B
- (01)00884838067684(21)02NK5J
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 →Related recalls
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