Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800
Summary
The FDA issued a Class II for Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic C by AGFA Healthcare Corp.. Reason: It is possible to exceed the maximum allowed Air Kerma rate (AKR) of 88mGy/min for pulsed fluoro exams. This can happen in case the framerate is incr.
Details
Source
Device Recall
External ID
Z-0923-2026
Action Date
2025-12-31
Status
Ongoing
Category
device
Product Description
Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800
Lot/Code Info: N/A
Quantity Affected: 35
Reason for Recall
It is possible to exceed the maximum allowed Air Kerma rate (AKR) of 88mGy/min for pulsed fluoro exams. This can happen in case the framerate is increased on the NX workstation when ABS is not enabled.
Distribution
U.S. Nationwide distribution.
Type: FDA Mandated
Recall Initiated: 2025-11-18
Company
Greenville, SC
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 103 device recalls issued in the same week, part of 403 device-related FDA actions this month.
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 Corp.) 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 Corp. have FDA actions?
This is the only FDA action we have on record for AGFA Healthcare Corp. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0923-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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