Philips recalls specific C8-4v Transducer Probes due to labeling clarification for useful life in the field. Affected units have unique model numbers and UDI codes listed. No safety risk, but labeling update required for proper use.
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Philips is recalling certain C8-4v Transducer Probes to clarify their useful life labeling in the field. This is a labeling update to ensure proper usage, not a safety hazard. No action is needed to prevent injury.
The recall is for labeling clarification to define the useful life of ultrasound transducers in the field. This is not a safety hazard but a labeling update to ensure proper usage and maintenance. The hazard mechanism is informational, not physical or safety-related.
Users of Philips C8-4v Transducer Probes with the listed model numbers and UDI codes are affected. Healthcare professionals using these probes for ultrasound imaging are most at risk due to potential mislabeling.
Check if your probe has model numbers 989803002685, 989605416131, 989605408153, 989605430232, 989605416141, 989605364943, 989605388111, 989605387261, 989605408151, 989605361973, 989605408141, 989605430242, 989605364941 or UDI codes starting with (01)00884838067981(21) followed by specific characters.
Verify your probe's model number or UDI code against the list provided in the recall notice.
No, this recall is for labeling clarification to define the useful life of the transducers in the field. There is no safety risk.
No action is required. This is a labeling update to ensure proper usage, not a safety hazard.
Check your probe's model number or UDI code against the list of affected units provided in the recall notice.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-2357-2025 — Philips Philips Hello, I own a Philips that is covered by recall Z-2357-2025 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.