Philips OMNI II TEE transducer labelling updated to define useful life
Philips is recalling two OMNI II TEE Ultrasound Transducers to provide clarification and labelling that defines the useful life of ultrasound transducers in the field.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: Rubric level 1 covers documentation issues, and this FDA Class III recall exists to add labelling defining useful life, with no defect or hazard described.
Plain-English summary
Philips Ultrasound, Inc is recalling the Philips OMNI II TEE Ultrasound Transducer. About 2 units were distributed nationwide in the United States. The FDA has classified this recall as Class III.
The recall was initiated to provide clarification and labelling to define the useful life of ultrasound transducers in the field. The source record does not describe a defect, malfunction or hazard in the transducer itself.
Affected product is model number 989605440792, serial numbers 02P8MV and 02MH3J.
Facilities can identify affected transducers by the model and serial numbers above, and may contact Philips Ultrasound, Inc for further information.
The recalled product
- Product
- Philips OMNI II TEE Ultrasound Transducer
- Manufacturer
- Philips Ultrasound, Inc
- Category
- Medical Device — Ultrasound
- Affected units
- 2
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 (4)
- Model No. 989605440792
- UDI: (01)00884838067660(21)02P8MV
- Serial No. 02P8MV
- 02MH3J.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 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 11 products in this recall →Related recalls
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