X3-1 ultrasound probes recalled for labelling defining device useful life
X3-1 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 X3-1 Transducer Probe is being recalled under model numbers 989605388101 and 21715A. No UDI is listed for these probes; affected units are identified by serial numbers 02YHPN and 02JK1H. 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
- X3-1 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 (5)
- Model No. 989605388101
- 21715A
- UDI: N/A
- Serial No. 02YHPN
- 02JK1H.
Distribution
Distributed nationwide across the United States.
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