Philips recalls OMNI II TEE Ultrasound Transducers for labeling clarification on useful life in field use. This does not pose a safety risk but requires updated labeling for proper maintenance.
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Philips is recalling its OMNI II TEE Ul:trasound transducers for labeling clarification to define their useful life in field use. This recall does not involve a safety hazard but ensures proper maintenance guidance.
The recall addresses labeling to clarify the useful life of ultrasound transducers in field use. This ensures proper maintenance and usage guidance without posing a safety risk.
Healthcare professionals using Philips OMNI II TEE Ultrasound Transducers for medical imaging are likely affected. Patients using these devices are not at risk as the recall is for labeling clarity.
Check for model number 989605440792 on the transducer. The unique device identifier (UDI) starts with (01)00884838067660(21)02P8MV and serial numbers include 02P8MV or 02MH3J.
Check the transducer for updated labeling that clarifies the useful life in field use.
No, this recall is for labeling clarification to define the useful life of the transducers in field use. It does not pose a safety risk.
No, the recall does not require stopping use. The transducer can continue to be used with updated labeling for proper maintenance.
The recall does not specify a disposal or return action. Review the labeling for updated useful life information.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-1623-2026 — Philips Philips Hello, I own a Philips that is covered by recall Z-1623-2026 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.
