L15-7io Transducer Probe Recall: Labeling Clarification on Useful Life
Philips Ultrasound recalls 171,322 L15-7io transducer probes nationwide to provide labeling clarification 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 is an FDA Class III device recall involving a documentation issue—labeling clarification for useful-life definition. Per the severity rubric, documentation issues are classified as Level 1 (Low).
Plain-English summary
Philips Ultrasound, Inc. is recalling the L15-7io Transducer Probe. The recall affects 171,322 units distributed nationwide in the United States.
The recall is issued to provide clarification and labeling that defines the useful life of ultrasound transducers in the field.
The recalled product
- Product
- L15-7io Transducer Probe
- Manufacturer
- Philips Ultrasound, Inc
- Hazard
- labeling-deficiency
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. 989605387852
- 989605438421
- 989605387341
- 989605428532
- 989605391083
- 989605412042
- 989605412082
- 989605418963
- 989605387851
- UDI: (01)00884838061491(21)B2Y4MR
- (01)00884838061491(21)B2YR9K
- (01)00884838061491(21)F0DWM3
- (01)00884838061491(21)F084NQ
- (01)00884838061491(21)F0D244
- (01)00884838061491(21)F0F19W
- (01)00884838061491(21)F0G2RJ
- (01)00884838061491(21)F0K6X7
- (01)00884838087057(21)B2C14V
- (01)00884838061491(21)B1PJC0
- (01)00884838061491(21)B24YWK
Distribution
Distributed nationwide across the United States.
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