CLASS II ONGOING Device recall · Reported 8 Jul 2020 · FDA Enforcement Report
Fujifilm Synapse PACS recalled by Fujifilm Medical Systems U.S.A
Fujifilm Medical Systems U.S.A is recalling Fujifilm Synapse PACS, distributed nationwide in the US. The recall was initiated on 22 May 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2471-2020
- FDA event ID
- 85793
- Recalling firm
- Fujifilm Medical Systems U.S.A, Lexington, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 May 2020
- FDA classified
- 30 Jun 2020
- Reported
- 8 Jul 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 22 May 2020 | Recall initiated by company | |
| 30 Jun 2020 | Classified by FDA | +39 days |
| 8 Jul 2020 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Fujifilm Synapse PACS Software Version 5.5.x and 5.7.x- intended as interface to the FUJIFILM Synapse PACS Software (Server)
Where it was distributed
Nationwide
Questions about this recall
Is Fujifilm Synapse PACS recalled?
Yes. Fujifilm Medical Systems U.S.A recalled Fujifilm Synapse PACS on 22 May 2020. The recall is Class II and its status is Ongoing. Recall number Z-2471-2020.
Why was it recalled?
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
Which lots are affected?
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 SY-01-01482450 SY-01-01489350 SY-01-01558860 SY-01-01573510 SY-01-00822790 SY-01-0080087769 SY-03-00070210 SY-01-07214790 SY-01-01717500-15 SY-01-00398300-10 SY-01-0080072627 SY-01-0080055858 SY-01-0080055213
Where was it sold?
Nationwide
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Fujifilm Medical Systems U.S.A
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