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Fujifilm Medical Systems U.S.A., Inc. Recall 87579

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).

Fujifilm Medical Systems U.S.A., Inc. Recall 87579 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1348-2021
Event ID87579
Event DescriptionSynapse 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 TypeDevices
DistributionWorldwide 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.
Quantity839 systems
Recall ReasonThe wrong patient information may be displayed in the viewer or PowerJacket.
Device Classification20210414
Device Code InfoSoftware version: 5.1 to 5.7.200
Center Classification Date20210402
Recall Initiation Date20210302
Recalling FirmFujifilm Medical Systems U.S.A., Inc.
Initial Notification Letter
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