Fujifilm Synapse PACS: Risk of Wrong Patient Info Display

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Recalling firmFujifilm Medical Systems U.S.A., Inc.81 Hartwell Ave Ste 300, N/A · Lexington, MA 02421-3160

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Fujifilm is recalling specific versions of its Synapse PACS software for radiology imaging systems. This recall is because the software might show the wrong patient information in the viewer or PowerJacket, which could lead to medical errors if used in patient care.

Why it’s dangerous

The software may display incorrect patient information in the viewer or PowerJacket. This could result in medical errors if healthcare providers rely on the wrong patient data for treatment decisions.

Who’s affected

Healthcare facilities using Fujifilm Synapse PACS software versions 5.1 to 5.7.200 for radiology imaging are likely affected. Medical staff handling patient images with this software version are at risk of potential errors.

How to tell if you have this one

Check if you have Fujifilm Synapse PACS software versions 5.1 through 5.7.200 installed on your off-the-shelf PC. The software is used for radiology imaging systems and is networked with Fujifilm Synapse PACS Software (Server).

Brand
Fujif: Medical Systems
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Version
Verify your Synapse PACS software version by checking the software settings or documentation.

✎ GovInfoNow

Questions people ask

Is this software dangerous for patients?

The recall states there is a risk of displaying wrong patient information, which could lead to medical errors. However, the specific risk level is not described as causing serious injury in normal use.

How can I update the software?

The recall record does not mention any update instructions or remedy steps.

What versions of the software are affected?

Software versions 5.1 to 5.7.200 are affected.

Take action

Contact Fujif: Medical Systems

We’ve drafted a message you can send Fujif: Medical Systems to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-1348-2021 — Fujif: Medical Systems Fujif: Medical Systems

Hello,

I own a Fujif: Medical Systems that is covered by recall Z-1348-2021 from Fujif: Medical Systems.

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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Where this comes from

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.

Official source: FDA Recall #Z-1348-2021 (March 2, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1348-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Fujifilm Medical Systems U.S.A., Inc. recalls Synapse PACS - Radiological Image Processing System - Product Usage: intended for use, as a web based application, on

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