Echonous Inc: Device Recall
Recall #Z-2325-2024 · 05/09/2024
Class II: Risk
Recall Details
- Recall Number
- Z-2325-2024
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Echonous Inc
- Status
- Ongoing
- Date Initiated
- 05/09/2024
- Location
- Redmond, WA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 272
Reason for Recall
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.
Product Description
Kosmos on iOS impacting iOS, Model Numbers: P007639, P007944, software is part of a general-purpose diagnostic ultrasound system.
Distribution Pattern
US: ID, TX, WI, KS, IL, GA, MI, CA, OH, FL, AK, UT, MD, NY, NV, CO, ND, WA, DC, LA, KY, MN, HI, NM, TN, NJ, ID, MI, VT, AZ, MO, AL, MA, NC OUS: Denmark, Switzerland, Austria, Italy, France, United Kingdom, Germany, Spain, Romania, Finland, Romania, Australia, India, Hong Kong, Thailand
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.