Recall Z-1004-2023— Agfa Healthcare NV

Name: FDA recall Z-1004-2023
Creator: U.S. Food and Drug Administration
Published: 2022-12-05

Class II · Ongoing

Class II FDA medical device recall by Agfa Healthcare NV, initiated 2022-12-05. It names one FDA 510(k) clearance: K170434. Product: Agfa HealthCare Enterprise Imaging XERO Viewer. Reason: There is a software defect that can cause issues with images..

Recalling firm: Agfa Healthcare NV
Classification: Class II
Status: Ongoing
Initiated: 2022-12-05
Firm location: Mortsel, N/A, Belgium

510(k) clearances named in this recall

1 on FDA's record

K170434 — Enterprise Imaging XERO Viewer 8.1Agfa Healthcare N.V.·cleared 2017-07-03

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

Agfa HealthCare Enterprise Imaging XERO Viewer

Reason for recall

There is a software defect that can cause issues with images.

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