Z-0073-2017Class II

Fujifilm Synapse PACS, Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx, version 4.3.xxx Medical imaging...

Name: Z-0073-2017 Fujifilm Synapse PACS, Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx, version 4.3.xxx Medical imaging...
Creator: Fujifilm Medical Systems U.S.A., Inc.
Published: 2016-09-15
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2016-09-15 / Terminated / root cause: software

FDA source

Fujifilm Medical Systems U.S.A., Inc. began a recall of Fujifilm Synapse PACS, Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx, version 4.3.xxx Medical imaging and information management system, SYNAPSE allows... on 2016-09-15. FDA classified it as Class II and gives the reason as "Image data for a patients image may not be correct". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0073-2017
Classification: Class II
Status: Terminated
Initiated: 2016-09-15
Posted: 2016-10-12
Terminated: 2019-02-20
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: Fujifilm Synapse PACS, Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx, version 4.3.xxx Medical imaging and information management system, SYNAPSE allows the archiving and distribution of image information from all modalities
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Image data for a patients image may not be correct
Root cause tag: software
FDA root cause: Software design
Action: The firm, FMSU, sent a "Medical Device Correction" letter dated September 15, 2016 to its customers. The letter describes the product, problem and actions to be taken. The firm will install a patch that corrects the issue (Synapse IPSS v1.3.1.0 Patch).Customers with Version 4.0 may upgrade to version 4.4 (will not require the patch) or upgrade to 4.1, 4.2, or 4.3 and install the patch. FMSU will install the patch on the server remotely if your site uses Active Monitoring. Your notification that the patch was installed will be your service ticket. For sites not using Active Monitoring, FMSU will schedule a time to install the patch on your server. Questions or concerns, contact the FUJIFILM Customer Support Center at 1-888-FUJIMED (1-800-385-4633) Option #1. International callers can access the FUJIFILM Customer Support Center by calling 1-203-602-3580.
Quantity in commerce: 251 units
Distribution: US Nationwide Distribution.
Product codes and lots: Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx, version 4.3.xxx

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0073-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0073-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-19	2016-10-12

Product code LLZ

K112439Class IISynapse Workstation Software Version 3.3.0Fujifilm Medical System U.S.A., Inc. / cleared 2011-10-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)