CuattroDR System Software Recalled for Potential Image Misattribution
Cuattro LLC is recalling CuattroDR System Software because images from previous patient studies may appear in later studies, potentially leading to misdiagnosis.
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 3/5 (High).
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: The recall involves a risk-of-harm product (medical device software) where injury or misdiagnosis has not yet been reported, fitting the 'High' severity criteria for theoretical hazards without confirmed adverse events.
Plain-English summary
Cuattro LLC is recalling 9 units of CuattroDR System Software (REF: SWR-00069-MD, UDI: B269SWR00069MD0, Product Version: 4.4.128). The recall is due to a potential software defect where an image from a previous patient study may appear in a later patient study.
This issue may result in the misdiagnosis of the correct patient. The affected units were distributed in the United States to New Jersey, Michigan, South Carolina, and North Carolina. No units were distributed outside the United States.
The source text does not specify specific actions for consumers or healthcare providers, such as contacting the manufacturer or halting use. Users should refer to official FDA channels or the recalling firm for specific instructions on how to proceed.
The recalled product
- Product
- CuattroDR System Software, REF: SWR-00069-MD, UDI: B269SWR00069MD0
- Manufacturer
- Cuattro LLC
- Category
- Medical Device — Software
- Affected units
- 9
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 (1)
- Product Version: 4.4.128
Distribution
Related recalls
Same hazard · misdiagnosis
See all →- HighPhilips EPIQ Elite Ultrasound System Recalled for Software Error
FDA (Devices) · 2026-09-30
- HighGE Healthcare Recalls Centricity PACS Software Due to Data Association Errors
FDA (Devices) · 2026-09-23
- HighGE Healthcare Recalls Centricity PACS Server V7 Due to Data Association Error
FDA (Devices) · 2026-09-23
- SevereNova Biomedical Recalls StatStrip Glucose Meters Due to Software Defect
FDA (Devices) · 2026-09-23
- HighGE Healthcare Enterprise Archive V8 Software Recalled for Data Association Errors
FDA (Devices) · 2026-09-23
Similar recalls
- HighSiemens syngo Dynamics Version 9.5 Recalled for Potential Image Misplacement
FDA (Devices) · 2012-08-29
- ModerateUnited Imaging uMI 550 PET/CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
- ModerateUnited Imaging CT System Recall Due to Software Image Visibility Issue
FDA (Devices) · 2026-10-07
- SevereBrainlab ExacTrac Dynamic Radiation Therapy System Software Recall
FDA (Devices) · 2021-03-17
- HighOrtho-Clinical Diagnostics Recalls VITROS XT 7600 Systems Due to Software Error
FDA (Devices) · 2019-05-01
- HighVITROS Diagnostic System Software Defect May Cause Erroneous Patient Results
FDA (Devices) · 2024-03-13