Philips L18-5 Transducer Probe Recall for Useful Life Labeling Clarification
Philips is recalling 171,322 L18-5 Transducer Probes nationwide to provide clarification and labeling defining the useful life of ultrasound transducers.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This Class III recall addresses labeling clarification regarding ultrasound transducer useful life definition. No hazard, injury, illness, or safety risk is stated in the source text. The issue is informational and labeling clarification in nature, consistent with Class III recalls which are typically scored 1 or 2.
Plain-English summary
Philips Ultrasound, Inc. is recalling 171,322 L18-5 Transducer Probes distributed nationwide. The recall affects Model Nos. 989605409582 and 989605438531.
The recall is being conducted to provide clarification and labeling that defines the useful life of ultrasound transducers in the field.
Healthcare facilities and practitioners using the L18-5 Transducer Probe should review updated labeling from Philips Ultrasound regarding the definition of useful life for their transducers. Contact Philips Ultrasound, Inc. for additional information regarding this recall and clarification.
The recalled product
- Product
- L18-5 Transducer Probe
- Manufacturer
- Philips Ultrasound, Inc
- Hazard
- labeling-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. 989605409582
- 989605438531
- UDI: (01)00884838061590(21)B211XD
- (01)00884838061590(21)B29X8C
- (01)00884838061590(21)B2VJ24
- (01)00884838061590(21)F010Y2
- (01)00884838061590(21)F04JYB
- (01)00884838061590(21)F06LTM
- 010088483806159021F024QP
- (01)00884838061590(21)B23T88
- (01)00884838061590(21)B2KLW4
- (01)00884838061590(21)B2LL93
- (01)00884838061590(21)F0DJP0
- (01)00884838061590(21)B1ZQTL
- (01)00884838061590(21)B2ZCHP
- (01)00884838061590(21)B1NXX9
- (01)00884838061590(21)B1QBQ0
- (01)00884838061590(21)F01CK2
- (01)00884838061590(21)B2T427
- (01)00884838061590(21)B2X16F
Distribution
Distributed nationwide across the United States.
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