Report a problem

Report a problem with a Synthology product.

Anyone can use this form — clinicians, biomedical engineers, IT staff, patients, family members. You don’t need to be a customer. You don’t need to know the exact product version. You don’t need an account. We’ll take what you give us.

Synthology is an ISO 13485–aligned firm whose software products are non-device under FD&C Act §520(o)(1)(D). Even though our products are not FDA-regulated devices, we maintain a public complaint-handling channel as a customer service: every submission is logged into a regulated Complaint record in SynthQMS with the same discipline a regulated firm would apply, and reports indicating patient harm or potential harm receive expedited internal review.

If a patient is currently being harmed or you believe a software problem is causing immediate clinical risk — do not wait for a web form.

Call us directly at +1 850 607 3631 and email complaints@synthologysolutions.com . For separate suspected security vulnerabilities, see our Coordinated Vulnerability Disclosure program.

Fields marked * are required. The rest are optional — share what you know.

1. About the product

Which product is this about? *

Product version

Date of event

Where is the software installed?

2. What happened

Describe what happened. *

In your own words. What did you observe? What were you trying to do? What did the software do (or not do)? Don’t worry about technical phrasing.

Did this involve patient harm or potential for harm? *

This question determines whether your report triggers our expedited patient-safety review. If you’re unsure, pick the closest answer — we’ll follow up.

No patient harm or potential for harm. Operational issue / annoyance / data display problem with no clinical impact. Potential for harm, but no actual harm occurred. A near-miss — the issue could have caused harm under different circumstances. Patient harm occurred. Including delayed diagnosis, repeated procedure / scan, wrong-patient images, or any clinical adverse event. Please describe in the previous field. I don’t know / prefer not to say.

Has this happened more than once?

3. About you (optional)

You can submit this report anonymously. Providing contact information lets us follow up with questions or close the loop with you on what we found.

Your name

Your email

Organization

Your role

Yes, I’d like Synthology to follow up with me about this report (requires email above).

We acknowledge every report within 5 business days.

Submissions are written directly into the SynthQMS Complaint queue under our ISO 13485–aligned quality system and retained per our privacy notice and our controlled retention policies (typically 6 years for general records, longer for safety-related complaint records).

What happens after you submit

1

Logged immediately

Your report becomes a regulated Complaint record in our quality system, with an immutable timestamp and ID.
2

Within 5 business days

Acknowledgment if you provided an email. Expedited patient-safety review begins if patient harm or potential harm was indicated.
3

Investigation + closure

Root-cause analysis, corrective action where warranted (CAPA), and closure with reply to you when contact details were provided.

Regulatory framing

Our products are non-device software under FD&C Act §520(o)(1)(D). We run this complaint channel voluntarily, with the complaint-handling discipline of our ISO 13485–aligned quality system. Reports of patient harm or potential harm receive expedited internal review. See our regulatory posture page for the full framework.

Prefer email?

complaints@synthologysolutions.com

Same complaint queue, same regulated record.

Not a complaint?