Home / Recalls / Fujifilm Medical Systems U.S.A., Inc. / Z-1348-2021

Z-1348-2021 Class II Ongoing

Recalled by Fujifilm Medical Systems U.S.A., Inc. — Lexington, MA

Recall Details

Product Type
Devices
Report Date
April 14, 2021
Initiation Date
March 2, 2021
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
839 systems

Product Description

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).

Reason for Recall

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

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.

Code Information

Software version: 5.1 to 5.7.200

Other recalls by Fujifilm Medical Systems U.S.A., Inc.

  • Z-1775-2021 Class II — Synapse Cardiovascular (Synapse CV). Software Versions: 6.0 to 6.2.1 The Syna (April 30, 2021)
  • Z-1412-2021 Class II — ¿TASWako Chip Cassette is part of the Wako ¿TASWako i30 kit (February 18, 2021)
  • Z-0932-2021 Class III — Wako HDL-C/LDL-C Calibrator - Product Usage: designed to be used with Wako L-Typ (December 22, 2020)
  • Z-0918-2021 Class II — FUJIFILM Synapse PACS Software: versions 7.0.0 and 7.0.1 - Product Usage: inten (December 11, 2020)
  • Z-0878-2021 Class II — Synapse PACS Software Versions 5.1 and higher (September 11, 2020)
  • Z-0282-2021 Class II — Synapse PACS Software Version 5.6.1 - Product Usage: intended for use as a web b (September 11, 2020)
  • Z-2471-2020 Class II — Fujifilm Synapse PACS Software Version 5.5.x and 5.7.x- intended as interface t (May 22, 2020)
  • Z-2441-2019 Class II — Fujifilm FDR Go Plus mobile X-ray system (July 19, 2019)
  • Z-1040-2019 Class II — Fujifilm FDR Go PLUS, Mobile X-Ray System Product Usage: This device is int (January 15, 2019)
  • Z-0659-2018 Class II — Aspire HD (for FDR-1000AWS) The Fujifilm Digital Mammography System, Aspire H (August 4, 2017)