Fujifilm Synapse PACS Software Version 5.5.x and 5.7.x- intended as interface to the FUJIFILM Synapse PACS…
Medical device recall Z-2471-2020. Published in FDA’s Enforcement Report on Jul 8, 2020.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jul 8, 2020. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 135 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Lateromedial (LM) and Lateromedial Oblique (LMO) Orientation Markers may be displayed incorrectly on the 3D TOMO slider bar. In addition, the slice location of the image and/or the slice direction could be incorrect as well, and result in misdiagnosis
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Fujifilm Synapse PACS Software Version 5.5.x and 5.7.x- intended as interface to the FUJIFILM Synapse PACS Software (Server)
135 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: SY-01-00358350-11 SY-01-00048100 SY-01-01421950-151 SY-01-0080093778 SY-01-00745300 SY-01-0080087818 SY-01-00358350-16 SY-01-00544800 SY-01-01333000-34 SY-01-07012810 SY-01-0080082385 SY-01-0080078513 SY-01-07059500…
Every code shown here, 1,999 characters
Serial Numbers: SY-01-00358350-11 SY-01-00048100 SY-01-01421950-151 SY-01-0080093778 SY-01-00745300 SY-01-0080087818 SY-01-00358350-16 SY-01-00544800 SY-01-01333000-34 SY-01-07012810 SY-01-0080082385 SY-01-0080078513 SY-01-07059500 SY-01-01333000-07 SY-01-01333000-20 SY-01-01333000-34 SY-01-07302600 SY-01-00127000 SY-01-07038976 SY-01-01487000-02 SY-01-00272120 SY-01-00349940 SY-01-00233520 SY-01-0080087409 SY-01-00233710 SY-01-00358350-03 SY-01-00236550 SY-01-0052282 SY-01-00254800-02 SY-01-000254800 SY-01-00269450 SY-01-07039120-01 SY-01-00272350-01 SY-01-00272410 SY-01-00106300 SY-01-00316710 SY-01-00277570-04 SY-01-00322350 SY-01-00322360 SY-01-07055566 SY-01-00493810-327 SY-01-01487000-01 SY-01-07060430-01 SY-01-80096794 SY-01-0079187 SY-01-09003000 SY-01-00465550 SY-01-00493810-112 SY-02-01138010-47 SY-01-00463100 SY-01-00493810-340 SY-01-0080092404 SY-01-00586560 SY-01-00591100 SY-01-00593500-01 SY-01-0080076025 SY-01-01447400-01 SY-01-00493810-155 SY-01-07127057 SY-0180097541 SY-01-00605610 SY-01-00616700-02 SY-01-0080053255 SY-01-0080080176 SY-01-00658580-01 SY-01-00228750-01 SY-01-01687500 SY-01-0080057825 SY-01-00693860 SY-01-0080071248 SY-01-00798760 SY-01-00804700-01 SY-01-0074955 SY-01-0080055290 SY-01-0080074389 SY-01-07160281 SY-01-0077489 SY-01-00873500 SY-01-07163410 SY-0080053050-001 SY-01-00103613 SY-01-00899150 SY-01-00816310 SY-01-0080094741 SY-01-07182322 SY-01-00971200 SY-01-0080092600 SY-01-80097226 SY-01-01034770 SY-01-09625000 SY-01-01072260 SY-01-01446300 SY-01-00769050-01 SY-01-01079071 SY-01-00493810-137 SY-01-00439700-10 SY-02-00858500 SY-01-07274900-01 SY-01-00493810-157 SY-01-01421950-26 SY-01-01134010 SY-01-00082610 SY-01-07242000 SY-01-00493810-300 SY-01-00949090 SY-01-00493810-97 SY-01-0080073752 SY-01-00322221 SY-01-05050280-60 SY-01-08131000 SY-01-01255600-03 SY-01-01272111 SY-01-07264334 SY-01-01401510-02 SY-01-80060398 SY-01-00493810-54 SY-01-01430700 SY-01-01447400 SY-01-01451260 SY-01-01318310 SY-01-00529515 SY-01-01327350…
FDA’s list runs to 2,207 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Nationwide
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on May 22, 2020.
- FDA classified it on Jun 30, 2020.
- FDA’s Enforcement Report published it on Jul 8, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Fujifilm Medical Systems U.S.A., Inc., of Lexington, MA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 2,207 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.