Philips recalls OMNI III TEE Transducer Probes with specific model and serial numbers for clarification on field use life to ensure proper maintenance.
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Philips is recalling certain OMNI III TEE Transducer Probes to clarify their useful life in medical use. This helps healthcare providers ensure proper maintenance and avoid potential issues with the device's performance.
The recall focuses on providing clearer labeling for the useful life of ultrasound transducers in the field. This ensures healthcare providers can maintain the device properly and avoid potential issues with performance or accuracy.
Healthcare providers using the recalled OMNI III TEE Transducer Probes are affected. Patients using these probes for medical ultrasound imaging may be at risk if the device's useful life is not properly managed.
Check for model numbers 989605440702 or 21378A and specific UDI codes listed in the recall. Also, verify serial numbers like B1CW9T or 02Y7HM to confirm if your probe is affected.
Compare your probe's model number (989605440702 or 21378A) and serial number (e.g., B1CW9T, 02Y7HM) against the list provided in the recall.
Philips is recalling these probes to provide clearer labeling on their useful life in medical use, ensuring proper maintenance and avoiding potential performance issues.
No, the recall does not require stopping use. It focuses on clarifying the useful life for proper maintenance.
Check the model number (989605440702 or 21378A) and serial number against the list provided in the recall.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-2388-2025 — Philips Philips Hello, I own a Philips that is covered by recall Z-2388-2025 from Philips. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.