Data Foundry

Medical device recalls 2020

Fujifilm Synapse PACS Software Version 5 — Class II medical device recall Z-2471-2020

Ongoing recall by Fujifilm Medical Systems U.S.A., Inc., reported 2020-07-08, distributed nationwide. Lateromedial (LM) and Lateromedial Oblique (LMO) Orientation Markers may be displayed incorrectly on the 3D TO

Recall numberZ-2471-2020
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmFujifilm Medical Systems U.S.A., Inc., Lexington, MA, United States
Recall initiated2020-05-22
Classified2020-06-30
Reported by FDA2020-07-08
DistributedNationwide (US)
Quantity135 units
Serial numbersSY-0080053050-001, SY-01-000254800, SY-01-00048100, SY-01-00082610, SY-01-00103613, SY-01-00106300, SY-01-00127000, SY-01-00228750-01, SY-01-00233520, SY-01-00233710, SY-01-00236550, SY-01-00254800-02, SY-01-00269450, SY-01-00272120, SY-01-00272350-01, SY-01-00272410, SY-01-00277570-04, SY-01-00316710, SY-01-00322221, SY-01-00322350, SY-01-00322360, SY-01-00349940, SY-01-00358350-03, SY-01-00358350-11, SY-01-00358350-16 and 109 more

Product

Fujifilm Synapse PACS Software Version 5.5.x and 5.7.x- intended as interface to the FUJIFILM Synapse PACS Software (Server)

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2471-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.