FDAMay 9, 2024device
Kosmos on iOS impacting iOS, Model Numbers: P007639, P007944, software is part of a general-purpose diagnostic ultrasound system.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Ongoing
Brands named
echonous
UPCs
0935327800071709353278000762
Recall history
No related federal recalls on record for this brand yet.
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