Philips L11-3 Ultrasound Transducer Probe Labelling Clarification
Philips is recalling 171,322 L11-3 ultrasound transducer probes to provide clarification and labelling defining the devices' useful life. Units were distributed nationwide.
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 Class III recall addresses a labelling and clarification issue with no reported adverse events or illnesses. FDA Class III recalls are typically low to moderate severity; this scores Moderate due to the labelling clarification needed for proper device use.
Plain-English summary
Philips Ultrasound, Inc is recalling 171,322 units of the L11-3 Transducer Probe that were distributed nationwide in the United States.
The FDA has classified this as a Class III recall. The recall is being issued to provide clarification and labelling to define the useful life of these ultrasound transducer devices.
Healthcare facilities and professionals using these transducer probes should contact Philips Ultrasound, Inc to obtain clarification and updated labelling regarding the products' useful life.
The recalled product
- Product
- L11-3 Transducer Probe
- Manufacturer
- Philips Ultrasound, Inc
- Hazard
- labeling-defect
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. 989605388251
- 989605400511
- 989605400513
- 989605440762
- UDI: (01)00884838067639(21)B1Y3CY
- (01)00884838067967(21)F08RH4
- (01)00884838067639(21)B1Y33W
- (01)00884838067967(21)B1X2F6
- (01)00884838067639(21)B1RY1G
- (01)00884838067639(21)B1RXQ9
- (01)00884838067639(21)B305V2
- (01)00884838067967(21)B2H0PB
- (01)00884838067967(21)B2PQ4H
- (01)00884838067967(21)B2GZFN
- (01)00884838067967(21)B2PV1V
- (01)00884838067967(21)B2PTWK
- (01)00884838067967(21)B2PMRG
- (01)00884838067967(21)B2PMR8
- (01)00884838067967(21)F08MFD
- (01)00884838067967(21)B20DKD
Distribution
Distributed nationwide across the United States.
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