Synapse PACS - Radiological Image Processing System recall
Synapse PACS - Radiological Image Processing System - Product Usage: intended for use, as a web based application, on an off-the-shelf PC meeting or…
Why was Synapse PACS - Radiological Image Processing System recalled?
The wrong patient information may be displayed in the viewer or PowerJacket.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Software version: 5.1 to 5.7.200
- 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…
- Recalling firm
- Fujifilm Medical Systems U.S.A., Inc.
- Quantity
- 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.
- Recall date
- April 14, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)