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Synapse Mobility

Fujifilm Healthcare Americas Corporation · Model Synapse Mobility Base Package · UDI-DI 00854904006053

LLZ
10
510(k) clearances
19,695
Adverse events (41 deaths)
560
Recalls
634
Facilities

Description

Synapse Mobility is a feature-rich DICOM and Non-DICOM image and report viewer. Synapse Mobility utilizes the latest server side rendering technology to stream imaging securely and fast to any authorized user, with the ability to open within applications, directly from your EHR, or on our mobile device apps.

Recalls

DateFirmReason
2026-07-31GE HealthcareUnder certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be
2026-07-31GE HealthcareUnder certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be
2026-07-31GE HealthcareUnder certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be
2026-07-31GE HealthcareUnder certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be
2026-07-31GE HealthcareUnder certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be
2026-07-31GE HealthcareUnder certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be
2026-07-22FUJIFILM Healthcare Americas CorporationSoftware issue may cause the ruler measurement to be inaccurate.
2026-07-22Merge Healthcare, Inc.Software issue may cause measurements to be displayed inaccurately.
2026-06-30Merge Healthcare, Inc.Merge Healthcare has identified a potential issue that may cause thumbnails from a previously opened patient study to be displayed in the Thumbnail Bar while a different patient st
2026-06-30Merge Healthcare, Inc.Merge Healthcare has identified a potential issue that may cause thumbnails from a previously opened patient study to be displayed in the Thumbnail Bar while a different patient st

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.