Class 2 Device Recall DR 800 with Tomosynthesis

• Date Initiated by Firm: November 18, 2025
• Date Posted: December 22, 2025
• Recall Status: Open, Classified
• Recall Number: Z-0923-2026
• Recall Event ID: 98101
• 510(K)Number: K183275
• Product Classification: System, x-ray, tomographic - Product Code IZF
• Product: Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800
• Code Information: N/A
• Recalling Firm/ Manufacturer: AGFA Healthcare Corp.; 10 S Academy St; Greenville SC 29601-2632
• For Additional Information Contact: 864-421-1815
• Manufacturer 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.
• FDA Determined Cause: Radiation Control for Health and Safety Act
• Action: AGFA NV notified Customers via a letter titled "IMPORTANT PRODUCT INFORMATION LETTER / DR 800", included Product Name, Symptom, Cause, Actions to be taken customer and manufacturers respectively: "Always enable ABS for pulsed fluoro exams. Actions being taken by the manufacturer: Agfa/local business partner will contact you to install a new generator software."
• Quantity in Commerce: 35
• Distribution: U.S. Nationwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = IZF