Fujifilm Synapse PACS software version 4.4.000 recall
Fujifilm Synapse PACS software version 4.4.000, Fujifilm Synapse PACS software version 4.4.001, Fujifilm Synapse PACS software version 4.4.004…
Why was Fujifilm Synapse PACS software version 4.4.000 recalled?
Synapse cannot display image files, DICOM SR files, and/or Annotation files. The "Image Not Loaded" message displays instead
What should I do if I have this product?
Review the official FDA enforcement record for current 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: 4.4.000, 4.4.001, 4.4.004, 4.4.010, 4.4.020
- Product
- Fujifilm Synapse PACS software version 4.4.000, Fujifilm Synapse PACS software version 4.4.001, Fujifilm Synapse PACS software version 4.4.004…
- Recalling firm
- Fujifilm Medical Systems U.S.A., Inc.
- Quantity
- 27 units
- Distribution
- US Distribution to states of: CA, FL, KS, NE, NY, and PA.
- Recall date
- June 29, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)