Echonous recalls specific Kosmos ultrasound models with iOS software that may cause inaccurate medical measurements in third-party diagnostic software, potentially leading to incorrect diagnoses.
Ultrasound system has a bug in affected iOS software, which after DICOM export, can cause inaccuracy in postprocessed measurements done in 3rd party software, such as PACS or other post-processing software, which may lead to inaccurate diagnoses or treatment.
Echonous is recalling two specific models of their Kosmos ultrasound devices due to a software bug that can cause inaccurate measurements when used with third-party diagnostic software. This could lead to incorrect medical diagnoses or treatments if the measurements are relied upon.
The software bug causes the ultrasound system to produce inaccurate measurements after exporting data in DICOM format. These inaccuracies can then be processed by third-party diagnostic software, potentially leading to incorrect medical diagnoses or treatments.
Healthcare providers using the affected Kosmos ultrasound models with iOS software may be at risk if they rely on measurements from third-party diagnostic software. Patients receiving care from these devices could be affected if the measurements are used for critical decisions.
Check for model numbers P007639 or P007944 on the device. The software version is either 1.0 or 2.1/2.2, and the device is part of a general-purpose diagnostic ultrasound system.
Identify the model number on the device, which should be P007639 or P007944.
The ultrasound software has a bug that causes inaccuracy in measurements after DICOM export, which can lead to incorrect diagnoses when processed by third-party diagnostic software.
Check for model numbers P007639 or P007944, with software versions 1.0 or 2.1/2.2.
The recall does not require immediate stop use; the risk is low and the device can continue to be used with caution.
We’ve drafted a message you can send Echonous to request your refund or repair — edit it as you like.
Subject: Recall Z-2325-2024 — Echonous Echonous Hello, I own a Echonous that is covered by recall Z-2325-2024 from Echonous. 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.
