Z-1348-2021Class II

Synapse PACS - Radiological Image Processing System -

Name: Z-1348-2021 Synapse PACS - Radiological Image Processing System -
Creator: Fujifilm Medical Systems U.S.A., Inc.
Published: 2021-03-02
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2021-03-02 / Open, Classified / root cause: software

FDA source

Fujifilm Medical Systems U.S.A., Inc. began a recall of Synapse PACS - Radiological Image Processing System - Product Usage: intended for use, as a web based application, on an off-the-shelf PC meeting or exceeding... on 2021-03-02. FDA classified it as Class II and gives the reason as "The wrong patient information may be displayed in the viewer or PowerJacket". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1348-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-03-02
Posted: 2021-04-02
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: Synapse PACS - Radiological Image Processing System - Product Usage: intended for use, as a web based application, on an off-the-shelf PC meeting or exceeding minimum specifications and networked with FUJIFILM Synapse PACS Software (Server).
Product code: LLZ System, Image Processing, Radiological
Reason for recall: The wrong patient information may be displayed in the viewer or PowerJacket.
Root cause tag: software
FDA root cause: Software design
Action: On March 2, 2021, FUJIFILM Medical Systems U.S.A., Inc. (FUJIFILM) issued an Urgent Medical Device Recall notice for the voluntary recall of Synapse PACS versions 5.1 and higher via certified mail.
Quantity in commerce: 839 systems
Distribution: Worldwide distribution - US Nationwide distribution including in the states of AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, VA, VT, WA, WI, WV, WY and the countries of United Arab Emirates, Angola, Argentina, Austria, Australia, Belgium, Bermuda, Brazil, Canada, Switzerland, Chile, Colombia, Costa Rica, Czechia, Germany, Spain, Finland, France, United Kingdom, Greece, Guatemala, Hong Kong, Indonesia, Israel, India, Italy, Jordan, Japan, Kuwait, Malta, Mexico, Malaysia, Netherlands, Peru, Philippines, Pakistan, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovenia, Slovakia, El Salvador, Thailand, Turkey, Uruguay, South Africa, Zimbabwe.
Product codes and lots: Software version: 5.1 to 5.7.200

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1348-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1348-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-04-14	2021-04-02

Product code LLZ

K160108Class IISynapse PACSFujifilm Medical Systems U.S.A, Inc. / cleared 2016-02-03

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)