Synaptive ImageDrive Clinical Software Recalled for Mammogram Image Quality Defect
Synaptive Medical Inc is recalling 28 units of ImageDrive Clinical software due to a defect that degrades mammogram image quality, 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 imaging software) where injury (misdiagnosis) has not yet been reported, fitting the 'High' severity criteria for theoretical harm without confirmed illness.
Plain-English summary
Synaptive Medical Inc is recalling 28 units of Synaptive ImageDrive Clinical software. The recall involves all versions of the software with part number SYN-0578- and unique device identifier (UDI) #(01) 00670082000139 (10)13x1. The products were distributed in the United States.
The recall is being issued because a software defect negatively affects the quality of images taken during diagnostic imaging, specifically mammograms. This degradation in image quality may result in misdiagnosis of patients.
Healthcare facilities and consumers who have this software installed should contact Synaptive Medical Inc for further instructions on how to resolve the defect. The source text does not specify a deadline or additional remediation steps.
The recalled product
- Product
- Synaptive ImageDrive Clinical
- Manufacturer
- Synaptive Medical Inc
- Category
- Medical Device — Software
- Affected units
- 28
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Synaptive Medical Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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