FDA Medical Device Recalls (openFDA)
Fujifilm Medical Systems U.S.A., Inc.: Synapse PACS Software Versions 5.1 and higher
- Recall number
- Z-0878-2021
- Recalling firm
- Fujifilm Medical Systems U.S.A., Inc.
- Product
- Synapse PACS Software Versions 5.1 and higher
- Status
- Open, Classified
- Initiated
- 2020-09-11
- Posted
- not on file
- Terminated
- not on file
- Reason
- There is a potential for the wrong patient information may be displayed in the viewer or PowerJacket. Additionally, the incorrect max standard uptake values (SUV) for PET ad CT studies may be returned for Siemens Modality.
- Root cause
- Device Design
- Action
- Letter was sent to all affected customers on 09/11/2020 stating the following: There have been no reported patient injuries associated with these issues. In an effort to ensure the highest level of customer satisfaction, FUJIFILM will offer an upgrade to Synapse PACS 5.7.200US to resolve these issues. Until your upgrade is scheduled and completed, you can continue to safely use Synapse PACS by following these additional instructions: 1. When selecting a patient off the PowerJacket or work list, please ensure that the patient information displayed in the viewer matches the desired patient and matches the PowerJacket. 2. If using a Siemens Modality, Max SUVs should not be used when rendering a clinical decision until the issue is corrected. Please complete and return the Field Action Verification Form attached on page 3 of this communication. Providing the response with the information requested is essential for ensuring appropriate action is taken.
- Quantity
- 235
- Distribution
- Software was distributed to medical facilities nationwide throughout the U.S.
- Lot, serial or model codes
- Software Versions 5.1, 5.2, 5.3, 5.4, 5.5, and 5.7.
- 510(k) numbers
- ["K160108"]
- 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