C10-3v transducer probes recalled to define ultrasound transducer useful life
C10-3v 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 C10-3v Transducer Probe is being recalled under model numbers including 989605409562, 989605438521, 989605381661, 989605381663, 989605398231, 989605381662 and 989605409561, 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
- C10-3v Transducer Probe
- Manufacturer
- Philips Ultrasound, Inc
- Category
- Medical Device — Ultrasound
- Hazard
- labelling-update
- useful-life
- class-iii
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. 989605409562
- 989605438521
- 989605381661
- 989605381663
- 989605398231
- 989605381662
- 989605409561
- 989605455171
- 989605492481
- 989605414531
- 989605406772
- 989605439232
- 21781A
- 989606708921
- 989605406771
- 989605414122
- UDI: (01)00884838061583(21)B1ZPMG
- (01)00884838061583(21)B3GL7D
- (01)00884838061583(21)B3PJJ1
- 010088483806158321F021FV
Distribution
Distributed nationwide across the United States.
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