Philips X3-1 ultrasound transducer labelling updated to define useful life
Philips is recalling the X3-1 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 X3-1 Ultrasound Transducer. About 17 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 989605440742, 989603002321, 989605388101 and 989605440741, across 17 listed serial numbers.
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 X3-1 Ultrasound Transducer
- Manufacturer
- Philips Ultrasound, Inc
- Category
- Medical Device — Ultrasound
- Affected units
- 17
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. 989605440742
- 989603002321
- 989605388101
- 989605440741
- UDI: (01)00884838067615(21)033TVZ
- (01)00884838067615(21)02Q8R3
- (01)00884838067615(21)02VLZV
- (01)00884838067615(21)02WND0
- (01)00884838067615(21)02ZWBH
- (01)00884838067615(21)02GP3C
- (01)00884838067615(21)03DTL6
- (01)00884838067615(21)02JK1H
- (01)00884838067615(21)02VMJ6
- (01)00884838067615(21)035Z89
- (01)00884838067615(21)031C21
- (01)00884838067615(21)02JL3W
- (01)00884838067615(21)03C066
- (01)00884838067615(21)02JK8D
- Serial No. 033TVZ
- 02Q8R3
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
Same manufacturer · Philips Ultrasound, Inc
See all →- LowPhilips 3D6-2 ultrasound transducer labelling updated to define useful life
FDA (Devices) · 2026-04-01
- LowPhilips S4-1 ultrasound transducer labelling updated to define useful life
FDA (Devices) · 2026-04-01
- LowPhilips X7-2 ultrasound transducer labelling updated to define useful life
FDA (Devices) · 2026-04-01
- LowPhilips C9-4 ultrasound transducer labelling updated to define useful life
FDA (Devices) · 2026-04-01
- LowPhilips OMNI III TEE transducer labelling updated to define useful life
FDA (Devices) · 2026-04-01
Same hazard · documentation update
See all →- LowPhilips Mini Multi TEE transducer labelling updated to define useful life
FDA (Devices) · 2026-04-01
- ModerateBD Alaris system labeling omits required TLS version for secure Wi-Fi
FDA (Devices) · 2026-04-01