Philips BP10-5ec Ultrasound Transducer Probe Recalled for Labeling Clarification
Philips Ultrasound is recalling 171,322 BP10-5ec Transducer Probes nationwide to provide clarification on labeling that defines product useful life.
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: FDA Class III recall with no reported illnesses or injuries. The recall involves labeling clarification regarding product useful life, which constitutes a minor labeling or documentation issue per the severity rubric.
Plain-English summary
Philips Ultrasound, Inc. is recalling 171,322 BP10-5ec Transducer Probes (Model No. 989605395642), which have been distributed nationwide throughout the United States.
The FDA has classified this recall as Class III. According to the FDA, the recall has been issued to provide clarification and labeling regarding the useful life of these ultrasound transducers.
Healthcare facilities and clinical users with these devices should review any updated labeling or communications from Philips regarding the useful life and appropriate use of the transducers.
The recalled product
- Product
- BP10-5ec 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. 989605395642
- UDI: (01)00884838061552(21)B29VPV
- (01)00884838061552(21)B29VQ6
- (01)00884838061552(21)B2CYJ4
- (01)00884838061552(21)F06M63
- (01)00884838061552(21)F06QYR
- (01)00884838061552(21)B2CY7P
- (01)00884838061552(21)F058R4
- (01)00884838061552(21)B2CY8T
- (01)00884838061552(21)F05YF6
- (01)00884838061552(21)F0628C
- (01)00884838061552(21)B29VPW
- (01)00884838061552(21)F064N9
- (01)00884838061552(21)F078HF
- (01)00884838061552(21)F05Y6Y
- (01)00884838061552(21)B2CYJJ
- (01)00884838061552(21)B2CYD7
- Serial No. B29VPV
- B29VQ6
- B2CYJ4
Distribution
Distributed nationwide across the United States.
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