ModerateClass IITerminated

FDA Devices recall · Reported June 29, 2016

Fujifilm Synapse PACS software version 4.4.000, Fujifilm Synapse PACS software version 4.4.001, Fujifilm Synapse PACS software version 4.4.004, Fujifilm Synapse PACS software version 4.4.010 and Fujifilm Synapse PACS software version 4.4.020 FUJIFILM Synapse Workstation Software (a Picture Archiving And Communications System) is intended to serve as the primary user interface for the processing of medical images for presentation on displays appropriate to the medical task being performed.

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on June 29, 2016. Severity: Moderate. Recall number: Z-2043-2016.

Q: Where was the recalled product distributed?

Distribution: US Distribution to states of: CA, FL, KS, NE, NY, and PA..

Q: Should I stop using a recalled medication or medical device?

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Synapse cannot display image files, DICOM SR files, and/or Annotation files. The "Image Not Loaded" message displays instead

Recall #: Z-2043-2016
Affected scope: 27 units
Initiated: May 10, 2016

Compiled from official public sources by the publisher. · Updated September 2026

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Fujifilm Medical Systems U.S.A., Inc. recalled Fujifilm Synapse PACS software version 4.4.000, Fujifilm Synapse PACS software version 4… - a moderate-severity action.

Fujifilm Synapse PACS software version 4.4.000, Fujifilm Synapse PACS software version 4… was recalled by Fujifilm Medical Systems U.S.A., Inc. in June 29, 2016. Reason: Synapse cannot display image files, DICOM SR files, and/or Annotation files. The "Image Not Loaded" message …. Check the official notice for the remedy. Verify recall #Z-2043-2016 with the FDA Devices before acting.

The recall

Fujifilm Medical Systems U.S.A., Inc. issued this moderate-severity FDA Devices recall-Synapse cannot display image files, DICOM SR files, and/or Annotation files. The "Image Not Loaded" message ….

Moderate
severity level: 27 units
affected scope: Class II
classification: June 29, 2016
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-2043-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

Fujifilm Synapse PACS software version 4.4.000, Fujifilm Synapse PACS software version 4.4.001, Fujifilm Synapse PACS software version 4.4.004, Fujifilm Synapse PACS software version 4.4.010 and Fujifilm Synapse PACS software version 4.4.020 FUJIFILM Synapse Workstation Software (a Picture Archiving And Communications System) is intended to serve as the primary user interface for the processing of medical images for presentation on displays appropriate to the medical task being performed. Also intended for installation on an off-the-shelf PC networked with Fuji Synapse PACS.

Reason for recall

Synapse cannot display image files, DICOM SR files, and/or Annotation files. The "Image Not Loaded" message displays instead

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	Z-2043-2016
Date reported	June 29, 2016
Date initiated	May 10, 2016
Recalling firm	Fujifilm Medical Systems U.S.A., Inc.
Firm location	Stamford, CT
Affected scope	27 units
Distribution	US Distribution to states of: CA, FL, KS, NE, NY, and PA.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

27 units units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) -

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-2043-2016) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

Synapse cannot display image files, DICOM SR files, and/or Annotation files. The "Image Not Loaded" message displays instead

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on June 29, 2016. Severity: Moderate. Recall number: Z-2043-2016.

Where was the recalled product distributed? ▼

Distribution: US Distribution to states of: CA, FL, KS, NE, NY, and PA..

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Similar severity · nearest report date

Same archive severity grade (Moderate), closest by report date among other firms and states.

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Similar Medical Devices · nearest report date

Same product category, closest by report date among other firms and states (deduped against the severity set).

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This recall: FDA Devices, reported June 29, 2016. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026