Kosmos on iOS impacting iOS, Model Numbers: P007639, P007944, software is part of a general-purpose diagnostic ultrasoun
Summary
The FDA issued a Class II for Kosmos on iOS impacting iOS, Model Numbers: P007639, P007944, software is part o by Echonous Inc. Reason: Ultrasound system has a bug in affected iOS software, which after DICOM export, can cause inaccuracy in postprocessed measurements done in 3rd party s.
Details
Source
Device Recall
External ID
Z-2325-2024
Action Date
2024-07-17
Status
Ongoing
Category
device
Product Description
Kosmos on iOS impacting iOS, Model Numbers: P007639, P007944, software is part of a general-purpose diagnostic ultrasound system.
Lot/Code Info: Model/UDI-DI/Software versions: P007639/09353278000717/1.0, P007944/09353278000762/ 2.1, 2.2.
Quantity Affected: 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.
Distribution
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
Type: Voluntary: Firm initiated
Recall Initiated: 2024-05-09
Company
Redmond, WA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 188 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Echonous Inc has 4 FDA actions in our database, including 1 recall and 3 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Echonous Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Echonous Inc have FDA actions?
Echonous Inc has 4 FDA actions in our database, including 1 recall and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2325-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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