MAUDE Adverse Event Report: ECHONOUS, INC. KOSMOS

Model Number	P007639, P0079444
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Echonous notified fda of a voluntary recall on (b)(6) 2024, within 10 working days from awareness.Fda initiated recall res 94709 on (b)(6), 2024.To date, echonous has received no complaints related to this issue.Given there was potential for serious injury, this mdr is being submitted.
Event or Problem Description
On (b)(6) 2024, echonous detected a software anomaly in the module responsible for creating dicom files for export or archive.Although the images and clips are being stored correctly in the dicom files created by our ios software, the pixel increment values put in the metadata are incorrect.As a result, the measurements performed on archived or exported dicom images/clips will be incorrect (10% to 15% with b-mode, ~ 2% in m-mode distance, cw/pw >10x).The defect is only present when performing measurements on exported/archived files using third-party dicom software.Measurements performed within the kosmos app are unaffected by this defect.Additionally, this software bug is only present in the ios version of the kosmos app.Kosmos and the kosmos android app remain unaffected by this defect.

• Brand Name: KOSMOS
• Common Device Name: KOSMOS
• Manufacturer (Section D): ECHONOUS, INC.; 8310 184 ave ne; building b, suite 200; redmond WA 98052
• Manufacturer (Section G): ECHONOUS, INC.; 8310 154th ave ne; building b, suite 200; redmond WA 98052
• Manufacturer Contact: joshua kim ; 8310 154th ave ne; building b, suite 200; redmond, WA 98052 ; 4254014102
• MDR Report Key: 22118943
• Report Number: 3013757696-2025-00001
• Device Sequence Number: 12556640
• Product Code: IYN
• UDI-Device Identifier: 09353278000717
• UDI-Public: (01)09353278000717(10)V1.0
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K212100
• Exemption Number: 0
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Recall
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: P007639, P0079444
• Device Lot Number: V 1.0, V2.1, V2.2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/30/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RES 94709
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown