C10-4ec ultrasound transducer probes recalled to add useful life labelling
C10-4ec Transducer Probes are the subject of a recall issued to provide clarification and labelling defining 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; this is a labelling clarification with no product defect described, which the FDA classed as Class III.
Plain-English summary
The C10-4ec Transducer Probe is being recalled under model numbers 989605413712, 989605438601 and 989605391092, with UDI numbers listed in the recall notice. The recall covers 171,322 units distributed nationwide in the United States.
The action was taken to provide clarification and labelling to define the useful life of ultrasound transducers in the field. The FDA classified the action as Class III. The notice does not describe a defect in the probes.
Imaging sites should follow the manufacturer's instructions for applying the updated labelling information.
The recalled product
- Product
- C10-4ec Transducer Probe
- Manufacturer
- Philips Ultrasound, Inc
- Category
- Medical Device — Ultrasound
- Affected units
- 171,322
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. 989605413712
- 989605438601
- 989605391092
- UDI: (01)00884838061507(21)B2KPHY
- (01)00884838067837(21)B1JT51
- (01)00884838067837(21)B1JTFN
- (01)00884838067837(21)B1JTJY
- (01)00884838067837(21)B1MT19
- (01)00884838067837(21)B1MT9L
- (01)00884838067837(21)B1MT9X
- (01)00884838067837(21)B1MT9Y
- (01)00884838067837(21)B1MTDR
- (01)00884838067837(21)B1MTDX
- (01)00884838067837(21)B1MTDZ
- (01)00884838067837(21)B1MTY9
- (01)00884838067837(21)B1N32V
- (01)00884838067837(21)B1N33Y
- (01)00884838067837(21)B1N340
- (01)00884838067837(21)B1N34V
- (01)00884838067837(21)B1N352
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 69 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 69 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 · labelling update
See all →- LowS5-2 transducer probes recalled to add useful life labelling
FDA (Devices) · 2025-09-03
- LowS8-3t ultrasound probes recalled for labelling defining device useful life
FDA (Devices) · 2025-09-03
- LowOMNI III TEE transducer probes recalled to add useful life labelling
FDA (Devices) · 2025-09-03
- LowS4-1 Lumify transducer probes recalled to define transducer useful life
FDA (Devices) · 2025-09-03
- LowC9-5ec transducer probes recalled over useful life labelling clarification
FDA (Devices) · 2025-09-03