C9-3io Transducer Probe recall: Labeling Error
C9-3io Transducer Probe
Why was C9-3io Transducer Probe recalled?
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model No. 989605395612; UDI: (01)00884838061538(21)B2CYBN, (01)00884838061538(21)B0WM4Z, (01)00884838061538(21)B0WM4P; Serial No. B2CYBN, B0WM4Z, B0WM4P.
- Product
- C9-3io Transducer Probe
- Recalling firm
- Philips Ultrasound, Inc
- Quantity
- 171,322 units
- Distribution
- US Nationwide distribution.
- Recall date
- September 3, 2025
- Classification
- Class III
- Status
- Ongoing
- Agency
- FDA (device)