Recall Z-1271-2024— FUJIFILM Healthcare Americas Corporation

Name: FDA recall Z-1271-2024
Creator: U.S. Food and Drug Administration
Published: 2024-01-10

Class II · Ongoing

Class II FDA medical device recall by FUJIFILM Healthcare Americas Corporation, initiated 2024-01-10. It names one FDA 510(k) clearance: K190232. Product: Synapse PACS - Version 7.2.100. Reason: Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements..

Recalling firm: FUJIFILM Healthcare Americas Corporation
Classification: Class II
Status: Ongoing
Initiated: 2024-01-10
Firm location: Lexington, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K190232 — Synapse PACSFujifilm Corporation·cleared 2019-03-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Synapse PACS - Version 7.2.100

Reason for recall

Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements.

Data sourced from openFDA. This site is unofficial and independent of the FDA.