Philips OMNI III TEE transducer labelling updated to define useful life
Philips is recalling the OMNI III TEE Ultrasound Transducer to provide clarification and labelling that defines the useful life of ultrasound transducers in the field.
What this means for you
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 III TEE Ultrasound Transducer. About 75 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 covers model numbers 989605440701, 989605440702, 989605440772 and 989803001561, across the serial numbers listed in the FDA enforcement record.
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 III TEE Ultrasound Transducer
- Manufacturer
- Philips Ultrasound, Inc
- Category
- Medical Device — Ultrasound
- Affected units
- 75
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. 989605440701
- 989605440702
- 989605440772
- 989803001561
- UDI: (01)00884838067585(21)02ZTTT
- (01)00884838067585(21)B0X7MD
- (01)00884838067585(21)02VWNV
- (01)00884838067585(21)02JQPG
- (01)00884838067585(21)02PCMT
- (01)00884838067585(21)0341PG
- (01)00884838067585(21)02QLMQ
- (01)00884838067585(21)B0JFCN
- (01)00884838067585(21)03C009
- (01)00884838067585(21)02Y7HM
- (01)00884838067585(21)02VTGK
- (01)00884838067585(21)037CHG
- (01)00884838067585(21)03G0BB
- (01)00884838067585(21)02WH6F
- (01)00884838067585(21)02QK2L
- (01)00884838067585(21)037F68
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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