Z-0923-2026Class II

Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800

Name: Z-0923-2026 Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800
Creator: AGFA Healthcare Corp.
Published: 2025-11-18
License: https://open.fda.gov/license/

AGFA Healthcare Corp. / initiated 2025-11-18 / Open, Classified

FDA source

AGFA Healthcare Corp. began a recall of Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800 on 2025-11-18. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0923-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-11-18
Posted: 2025-12-22
Recalling firm: AGFA Healthcare Corp.
Product: Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800
Product code: IZF System, X-Ray, Tomographic
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 root 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.
Product codes and lots: N/A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0923-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0923-2026	Class II	Ongoing	FDA Mandated	2025-12-31	2025-12-22

Product code IZF

K183275Class IIDR 800 with TomosynthesisAgfa N.V. / cleared 2019-02-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)