FirstAlerts
Recalls & Safety Alerts

FDA Expands Recall of FUJIFILM Synapse PACS Over Ruler Measurement Error

The FDA has expanded its recall of FUJIFILM Synapse PACS software to include additional versions, citing a risk of inaccurate ruler measurements.

5 reports on this incident · first at Aug 28, 2026, 11:15 a.m. ET

By AI ReporterFirst reported Aug 28, 2026, 10:00 a.m. ETWritten Aug 28, 2026, 11:54 a.m. ET
The U.S. Food and Drug Administration (FDA) has expanded its recall of FUJIFILM Synapse PACS software, according to an enforcement report published August 28, 2026. The recall, classified as , now covers version 7.4.310 of the software, which is used for medical imaging. The agency said the , posing a risk of temporary or medically reversible harm, though . The recall, initiated July 22, 2026, affects distributed in . The FDA advises users to . The recall number is , and the status is listed as . According to the FDA's recall database, this is the only enforcement action recorded for . The cause of the software issue has not been determined.

Earlier reports

  1. Aug 28, 2026, 11:52 a.m. ET

    FDA Reclassifies FUJIFILM Synapse PACS Recall as Class II

    The U.S. Food and Drug Administration has reclassified the recall of FUJIFILM Synapse PACS, version 7.4.310, as Class II, according to an enforcement report published August 28, 2026. The recall, initiated July 22, 2026, covers 6 units distributed in New York, Virginia, Kansas, Oregon, Ohio, and Australia. The agency's classification change means the product may cause temporary or medically reversible harm, with a remote chance of serious harm, per the FDA's recall definitions.

    The recall was prompted by a software issue that may cause the ruler measurement to be inaccurate. No injuries have been reported. The FDA advises users to perform M-mode ruler measurements on the ultrasound system itself and then transfer the study to Synapse PACS. The recall number is Z-3030-2026, and the status is open.

    The FDA's enforcement database records no other enforcement action by this firm. The cause of the software issue has not been determined.

  2. Aug 28, 2026, 11:23 a.m. ET

    FDA Reports Injuries in FUJIFILM Synapse PACS Recall Over Ruler Measurement Error

    The U.S. Food and Drug Administration (FDA) has received reports of injuries in connection with the recall of FUJIFILM Synapse PACS, according to an enforcement report published August 28, 2026. The agency did not specify the nature of the injuries or how they relate to the software issue.

    The recall, initiated July 22, 2026, affects version 7.4.310 of the software, distributed in New York, Virginia, Kansas, Oregon, Ohio, and Australia. The FDA classified it as Class II, its middle category, used when a product may cause temporary or medically reversible harm and the chance of serious harm is remote. The agency states the software issue may cause the ruler measurement to be inaccurate, and advises users to perform M-mode ruler measurements on the ultrasound system itself and then transfer the study to Synapse PACS.

    The FDA's enforcement database lists no other enforcement actions by FUJIFILM Healthcare Americas Corporation. The recall remains open.

  3. Aug 28, 2026, 11:21 a.m. ET

    FDA Closes Class II Recall of FUJIFILM Synapse PACS Over Ruler Measurement Error

    The U.S. Food and Drug Administration has closed the recall of FUJIFILM Synapse PACS, recall number Z-3030-2026, according to an FDA enforcement report. The agency considers the recall carried out. The recall was initiated on July 22, 2026, and reported on August 28, 2026.

    The recall affects version 7.4.310 of the software, distributed in New York, Virginia, Kansas, Oregon, Ohio, and Australia. The FDA classified it as Class II, its middle category, used where the product may cause temporary or medically reversible harm and where the chance of serious harm is remote. The reason for the recall is a software issue that may cause the ruler measurement to be inaccurate. No injuries have been reported.

    The remedy directs users to perform M-mode ruler measurements on the ultrasound system itself and then transfer the study to Synapse PACS. The FDA's database records no other enforcement action by this firm.

  4. Aug 28, 2026, 11:15 a.m. ETFirst report

    FDA Classifies FUJIFILM Synapse PACS Recall as Class II Over Ruler Measurement Error

    The U.S. Food and Drug Administration (FDA) has classified a recall of FUJIFILM Synapse PACS software as Class II, according to a report from Medical Daily. The recall, initiated on July 22, 2026, affects version 7.4.310 of the software and involves 6 units distributed in New York, Virginia, Kansas, Oregon, Ohio, and Australia. The recall number is Z-3030-2026.

    The FDA's enforcement report states that the software issue may cause the ruler measurement to be inaccurate. No injuries have been reported. The FDA's classification of Class II is its middle category, used where the product may cause temporary or medically reversible harm, and where the chance of serious harm is remote, according to the FDA's recall definitions.

    The remedy provided in the recall notice is to perform M-mode ruler measurements on the ultrasound system itself and then transfer the study to Synapse PACS. The recall status is open, and the FDA's database records no other enforcement action by this firm.

Was this report accurate and useful?

Sources

Revision history

  1. Version 128 Aug 2026, 15:54current

    First published.

  2. Version 128 Aug 2026, 15:15current

    First published.

  3. Version 128 Aug 2026, 15:23current

    First published.

  4. Version 128 Aug 2026, 15:52current

    First published.

  5. Version 128 Aug 2026, 15:21current

    First published.

How we work

This site models an investigative reporter rather than a wire desk. The aim is the most complete, accurate and timely account we can assemble — all three, not a trade between them. Reports go out within minutes of the coverage they are built from, carrying context a newsroom would otherwise need a day and a records request to gather: what has happened at this place before, what the operator’s record is, which aircraft it actually was.

Reports are built from primary sources — accident and court records, official registries, weather observations, agency statements — and from reputable news organisations, each named where their reporting is used. Facts are extracted before anything is written, and every one must be supported by a quotation found in the source itself; the model that writes the report is given only those verified facts and never sees the article, so it cannot introduce a detail no source stated.

Where sources disagree we publish the disagreement, attributed, rather than picking a figure. Where a fact comes from a record rather than a reporter, we say so, and the language matches: an instrument reading is never described as something anyone confirmed. Some things are deliberately withheld — a suspect is not named until an agency names them on the record, victims until families or officials release them — and corrections appear as visible revisions, never as silent edits.

None of that makes a report true. A quotation check proves a source said something, not that it was right, and an automated system can be confidently wrong in ways the checks do not catch. If something here is wrong, the feedback above is how it gets found. The full methodology, including what we refuse to publish.