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MEDICAL DEVICE RECALLMODERATE

FUJIFILM Synapse PACS Software

FUJIFILM Synapse PACS v7.4.310 recalled due to inaccurate ruler measurements.

What to do

Contact FUJIFILM Healthcare Americas Corporation to obtain the software update that corrects the ruler measurement issue. Until the update is applied, verify measurements using alternative methods and be aware that measurements may be inaccurate.

Recalled
Listed
Updated
Recall No.
Z-3030-2026
Agency
FDA
Firm
FUJIFILM Healthcare Americas Corporation
Recall ID
99529
Status
ONGOING

Recall at a glance

Quantity recalled
6 units

Why it was recalled

FUJIFILM Healthcare Americas Corporation is recalling Synapse PACS software version 7.4.310 because a software issue may cause the ruler measurement to be inaccurate, potentially leading to misdiagnosis or incorrect treatment decisions.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

FUJIFILM Synapse PACS software v7.4.310; radiological image processing system

UDI-DI
00854904006008, 00272120, 0080080176, 01318490, 80102732, 80057523, 00494020

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Other Software Defect recalls

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Editorial summary by Recall Canary · summary updated 2026-08-27 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification