Kosmos iOS Ultrasound Software Update Due to Measurement Accuracy Bug
Echonous Inc is recalling Kosmos ultrasound software for iOS due to a bug causing inaccurate measurements in DICOM exports, potentially leading to incorrect diagnoses.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with potential for measurement inaccuracy leading to diagnostic errors. The source text does not report any actual illnesses, injuries, or hospitalizations; the hazard is theoretical (potential for incorrect diagnosis or treatment). This meets the threshold for Score 3: risk-of-harm where injury has not yet been reported.
Plain-English summary
Echonous Inc is recalling Kosmos ultrasound system software for iOS (Model Numbers P007639 and P007944, software versions 1.0, 2.1, and 2.2). Approximately 272 devices are affected and have been distributed throughout the United States and internationally.
The recalled software contains a bug that can cause measurement inaccuracies when users perform DICOM export and postprocessing in third-party software such as PACS or other post-processing systems. These inaccuracies could lead to inaccurate diagnoses or inappropriate treatment decisions.
Healthcare facilities and practitioners using affected Kosmos devices should verify their software version and contact Echonous Inc for remediation options, which may include a software update.
The recalled product
- Product
- Kosmos on iOS impacting iOS, Model Numbers: P007639, P007944, software is part of a general-purpose diagnostic ultrasound system.
- Manufacturer
- Echonous Inc
- Hazard
- measurement-inaccuracy
- diagnostic-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model/UDI-DI/Software versions: P007639/09353278000717/1.0
- P007944/09353278000762/ 2.1
- 2.2.
Distribution
Distributed in 32 states:
- AK
- AL
- AZ
- CA
- CO
- DC
- FL
- GA
- HI
- ID
- IL
- KS
- KY
- LA
- MA
- MD
- MI
- MN
- MO
- NC
- ND
- NJ
- NM
- NV
- NY
- OH
- TN
- TX
- UT
- VT
- WA
- WI
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