Recall Z-2325-2024— Echonous Inc
Class II · Ongoing
Class II FDA medical device recall by Echonous Inc, initiated 2024-05-09. It names one FDA 510(k) clearance: K212100. Product: Kosmos on iOS impacting iOS, Model Numbers: P007639, P007944, software is part of a general-purpose diagnostic ultrasound system.. Reason: 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..
- Recalling firm
- Echonous Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-05-09
- Firm location
- Redmond, WA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Kosmos on iOS impacting iOS, Model Numbers: P007639, P007944, software is part of a general-purpose diagnostic ultrasound system.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.