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: How do I check if my product is affected by a recall?

Check the product description and recall number (Z-2043-2016) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

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 editorial team. · Updated July 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.

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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 FDA Devices action (record #Z-2043-2016) was formally reported on June 29, 2016, with the manufacturer initiating the action on May 10, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Fujifilm Medical Systems U.S.A., Inc. is listed as the recalling firm, operating out of Stamford, CT. Federal records list the affected scope as 27 units.

The documented reason for this recall is: Synapse cannot display image files, DICOM SR files, and/or Annotation files. The "Image Not Loaded" message displays instead Distribution data in the federal record shows the product reached: US Distribution to states of: CA, FL, KS, NE, NY, and PA.. Distribution scope 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, 3 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 recall sits in the database

Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. 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.

Severity

Moderate

Affected scope

27 units

Related Recalls

3 from same agency

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..

How do I check if my product is affected by a recall? ▼

Check the product description and recall number (Z-2043-2016) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

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.

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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported June 29, 2016. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.