Summary
The FDA issued a Class II for Agfa HealthCare Enterprise Imaging XERO Viewer by Agfa Healthcare NV. Reason: There is a software defect that can cause issues with images..
Details
Source
Device Recall
External ID
Z-1004-2023
Action Date
2023-02-01
Status
Ongoing
Category
device
Product Description
Agfa HealthCare Enterprise Imaging XERO Viewer
Lot/Code Info: Affected software versions include: XERO Viewer 8.1.4.100 or higher XERO Viewer 8.2.0.000 or higher XERO Viewer 8.2.1.000 or higher UDI/DI: 05400874000710
Quantity Affected: 110 units
Reason for Recall
There is a software defect that can cause issues with images.
Distribution
Distribution throughout US OUS distribution to Australia, Belgium, Brazil, Canada, Chile, Cyprus, France, Iceland, Ireland, Italy, Kenya, Luxembourg, Netherlands, Romania, Saudi Arabia, Spain, Sweden, United Kingdom, South Africa
Type: Voluntary: Firm initiated
Recall Initiated: 2022-12-05
Company
Mortsel, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 114 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Agfa Healthcare NV has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Agfa Healthcare NV) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Agfa Healthcare NV have FDA actions?
Agfa Healthcare NV has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1004-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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