Lower riskMedical device recall · FDA · Published April 30, 2021
Fujifilm Synapse CV Software 6.0-6.2.1: Patient ID Reuse Risk
Fujifilm recalls Synapse Cardiovascular software versions 6.0 to 6.2.1 due to potential patient ID reuse during database merges, which could lead to misidentification in medical records.
Software versions 6.0.4 to 6.2.1 using Advanced Reporting -possibility that a previously assigned internal patient database ID can be reused for a new patient. It was discovered that this value does not increase when a patient merge activity is executed in a specific sequence
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Contact the company
📍Recalling firmFujifilm Medical Systems U.S.A., Inc.81 Hartwell Ave Ste 300 · Lexington, MA 02421-3160
✎ GovInfoNow plain-language explainer
Fujifilm is recalling Synapse Cardiovascular software versions 6.0 to 6.2.1 because a flaw in how patient IDs are handled could cause the same ID to be reused for new patients after a specific database merge. This risk could lead to medical record errors if a patient's information is incorrectly linked to another person. Read more at govinfonow.com/recall/62631-fujifilm-synapse-cv-software-6-0-6-2-1-patient.
“Fujifilm Synapse CV Software 6.0-6.2.1: Patient ID Reuse Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62631-fujifilm-synapse-cv-software-6-0-6-2-1-patient. Based on FDA recall #Z-1775-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1775-2021%22&limit=1).
The FDA announced on April 30, 2021, that Fujifilm Medical Systems U.S.A., Inc. is recalling Synapse Cardiovascular software versions 6.0 to 6.2.1 due to a hazard involving patient data integrity. The recall was initiated voluntarily by the firm.
How to tell if you have it
Brand: Fujifilm Medical Systems
Product: Synapse Cardiovascular (Synapse CV)
Software Versions: 6.0 to 6.2.1
The hazard
The FDA stated that software versions 6.0.4 to 6.2.1 using Advanced Reporting may allow a previously assigned internal patient database ID to be reused for a new patient. This issue occurs when a patient merge activity is executed in a specific sequence, causing the value not to increase.
Context
GovInfoNow's records show Fujifilm Medical Systems U.S.A., Inc. has 13 other recalls on record since June 15, 2017. Other recent recalls of similar products include Fujifilm Synapse PACS (March 2, 2021), Fujifilm Wako TASWako i30 Chip Cassette (February 18, 2021), and Fujifilm Wako HDL-C/LDL-C Calibrator (December 22, 2020). Other recent recalls of similar products include GE Healthcare Enterprise Archive V8 Software (July 31, 2026), GE Healthcare Workflow Core Services V8 (July 31, 2026), and GE Healthcare Centricity Enterprise Archive V2/V3/V4 Software (July 31, 2026).
How to tell if you have this one
Check if you have Synapse Cardiovascular software versions 6.0 to 6.2.1 installed on your medical system. The product is used for patient management and reporting.
Brand
Fujifilm Medical Systems
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Update Software
Install the latest software version from Fujifilm Medical Systems to fix the patient ID reuse issue.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution and the countries of Canada, Bermuda, Israel, Hadassah Medical Center.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 3.2 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1775-2021 (April 30, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1775-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.