Synaptive Medical recalls ImageDrive Clinical software due to potential misdiagnosis from poor mammogram images. Affected units have specific UDI codes and part numbers.
A software defect negatively affects the quality of images taken during diagnostic imaging (mammograms) which may result in misdiagnosis.
Synaptive Medical is recalling its ImageDrive Clinical software because a defect can cause poor image quality in mammograms, potentially leading to misdiagnosis. This affects healthcare providers using the system for diagnostic imaging.
The software defect causes images taken during mammograms to be of lower quality. This could lead to misdiagnosis because the images might not show abnormalities clearly enough for accurate detection of breast cancer.
Healthcare providers using the Synaptive ImageDrive Clinical system for mammograms are most at risk. Patients receiving mammograms through this system may be affected if the software defect causes misdiagnosis.
Check for the product name 'ImageDrive Clinical' with part number SYN-057: 0578-00670082000139 (UDI code). The software is used in diagnostic imaging systems for mammograms.
Identify if your system has the part number SYN-0578 or UDI code (01) 00670082000139.
The recall is for the software that may cause poor image quality in mammograms, which could lead to misdiagnosis. If you have the affected software, contact Synaptive Medical for details.
Check for the part number SYN-0578 or UDI code (01) 00670082000139 on your system. The affected software is used in diagnostic imaging systems for mammograms.
The recall does not specify a remedy, so contact Synaptive Medical directly to discuss next steps.
We’ve drafted a message you can send Synaptive to request your refund or repair — edit it as you like.
Subject: Recall Z-1759-2020 — Synaptive Synaptive Hello, I own a Synaptive that is covered by recall Z-1759-2020 from Synaptive. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
