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Recall Observatory FDA recall evidence

Device 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).

Z-1348-2021

March 02, 2021

Class II

Product summary

Firm
Fujifilm Medical Systems U.S.A., Inc.
Event
Event 87579
Status
Ongoing
Classification
Class II
Quantity
839 systems
Official record key
device-enforcement:Z-1348-2021

Official wording

Reason: The wrong patient information may be displayed in the viewer or PowerJacket.

Code information: Software version: 5.1 to 5.7.200

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The wrong patient information may be displayed in the viewer or PowerJacket.