FDA Medical Device Recalls (openFDA)
Fujifilm Medical Systems U.S.A., Inc.: Synapse PACS Software Version 5.6.1 - Product Usage: intended for use as a web based application on an off-the shelf PC which meets or exceeds minimum specifications and is networked with a FUJIFILM Synapse PACS server.
- Recall number
- Z-0282-2021
- Recalling firm
- Fujifilm Medical Systems U.S.A., Inc.
- Product
- Synapse PACS Software Version 5.6.1 - Product Usage: intended for use as a web based application on an off-the shelf PC which meets or exceeds minimum specifications and is networked with a FUJIFILM Synapse PACS server.
- Status
- Terminated
- Initiated
- 2020-09-11
- Posted
- not on file
- Terminated
- 2021-11-17
- Reason
- FUJIFILM has become aware of the possibility that certain CT studies may report a much higher 3D Sphere MAX value than expected. This issue is specific to 3D Sphere - other density tools are not affected.
- Root cause
- Software change control
- Action
- Letter was sent to all affected customers on 09/11/2020 stating the following: FUJIFILM will offer an upgrade to Synapse PACS 7.1.100 to resolve this issue. Synapse PACS 7.1.100 is estimated to be available by the end of September. Until the patch is available, users can continue to safely use Synapse PACS by following these additional instructions: 1. Ensure that the 3D Sphere MAX value is within the spheres range. If the 3D Sphere MAX value is observed to be much higher than expected, the value should not be used when rendering a clinical decision until the issue is corrected. Customers should complete and return the Field Action Verification Form attached to the recall letter.
- Quantity
- 1
- Distribution
- US Nationwide distribution including in the state of Minnesota.
- Lot, serial or model codes
- Synapse Software Version 5.6.1
- 510(k) numbers
- ["K190232"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 1000513161
- Firm city
- Lexington
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28