Reported Jul 17, 2024 · Ongoing
Kosmos on iOS impacting iOS, Model Numbers: P007639, P007944, software is part of a general-purpose diagnostic…
Echonous Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Echonous Inc · 8310 154th Ave Ne Ste 200 Bldg B · Redmond, WA · 98052-6180
Is this the product you have?
- Kosmos on iOS impacting iOS
- Model NumbersP007639, P007944, software is part of a general-purpose diagnostic ultrasound system
- Lot codes and dates
- Model/UDI-DI/Software versions
P007639/09353278000717/1.0P007944/09353278000762/ 2.12.2
- Model/UDI-DI/Software versions
- Amount recalled
- 272
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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