Koios DS Breast Software Recalled for Missing Quality Documentation
Koios Medical is recalling 10 units of Koios DS Breast software due to insufficient documentation of required quality procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is due to documentation issues regarding quality procedures, which aligns with the 'Low' severity criterion for documentation issues.
Plain-English summary
Koios Medical, Inc. is recalling 10 units of the Koios DS Breast software application. The device is used by skilled physicians to assist in analyzing breast ultrasound images.
The recall was initiated after an internal audit revealed that the affected software versions were marketed for sale without sufficient documentation pertaining to certain required quality procedures. The affected versions include specific build and commit numbers ranging from 1.2 to 1.6.2.1.
The software was distributed to customers in New York, New Jersey, and Missouri. No specific instructions for consumers are provided in the source text, as the product is a professional medical device intended for use by skilled physicians.
The recalled product
- Product
- Koios DS Breast <series 1.0>. The device is a software application which assists skilled physicians in analyzing breast ultrasound images.
- Manufacturer
- Koios Medical, Inc.
- Category
- Medical Device — Software
- Hazard
- Affected units
- 10
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 (9)
- Models/Versions: 1.2.df61abccd836
- 1.2.576fd5569198
- 1.3.51a5fadf18dd
- 1.3.1.b5c53f1fc08d
- 1.3.1.694531bfb9c7
- 1.3.1.aaffb0cc2485
- 1.3.2.6a67eb8088ed
- 1.4.a7e352273dd6
- 1.6.1.1*
Distribution
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