Kosmos OTS iOS Software Package P007639Recalls & reported problems
Echonous, Inc. · Kosmos OTS iOS Software Package · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 09353278000717), received between May 30, 2025 and May 30, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Computer Software Problem” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Recalls naming this device
- May 9, 2024Open, Classified
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.
Z-2325-2024 · Root cause: Software Design Change · Recall details · FDA record ↗
Most reported problems
Device problems
- Computer Software Problem1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 30, 2025Computer Software Problem; Computer Software Problem
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.
Patient problems: Insufficient Information
MAUDE report 22118943 ↗
Other System, Imaging, Pulsed Echo, Ultrasonic devices
- EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE OLYMPUS GF TYPE UCT180Olympus Medical Systems Corp. · System, imaging, pulsed echo, ultrasonic1 recall8 deaths5,133 reports
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- Transducer X8-2t 989605455171Philips Ultrasound LLC · System, imaging, pulsed echo, ultrasonic8 recalls19 reports
- Transducer C10-3v 989605409562Philips Ultrasound LLC · System, imaging, pulsed echo, ultrasonic7 recalls0 reports
- Site~Rite 8 Ultrasound System 9770600YBard Access Systems, Inc. · System, imaging, pulsed echo, ultrasonic330 reports
- Transducer C9-2 989605391092Philips Ultrasound LLC · System, imaging, pulsed echo, ultrasonic5 recalls0 reports
- Transducer S5-1 989605412082Philips Ultrasound LLC · System, imaging, pulsed echo, ultrasonic5 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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