Z-2056-2019Class II

AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic

Name: Z-2056-2019 AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic
Creator: Agfa N.V.
Published: 2019-06-27
License: https://open.fda.gov/license/

Agfa N.V. / initiated 2019-06-27 / Terminated / root cause: design

FDA source

Agfa N.V. began a recall of AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Product Usage: The Agfa s DR 800 system is indicated for performing dynamic imaging... on 2019-06-27. FDA classified it as Class II and gives the reason as "The exposed area of fluo exams possibly does not match the active area of the detector within specified limits". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2056-2019
Classification: Class II
Status: Terminated
Initiated: 2019-06-27
Posted: 2019-07-30
Terminated: 2020-06-03
Recalling firm: Agfa N.V.
Product: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Product Usage: The Agfa s DR 800 system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence) of the following an anatomies/procedures: positioning fluoroscopy procedures, gastro-intestinal examinations, urogenital tract examinations, and angiography. It is intended to replace fluoroscopic images obtained through image intensifier technology. In addition, the system is intended for project radiography of all body parts. The DR 800 is not intended for mammography applications.
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
Reason for recall: The exposed area of fluo exams possibly does not match the active area of the detector within specified limits.
Root cause tag: design
FDA root cause: Device Design
Action: The firm sent notification letter dated June 27, 2019 to affected customers. The letter identified the affected product problem and actions to be taken. For questions about this matter,contact your local Agfa Imaging organization 1-877-777-2432 and please reference Problem Record. PRB2000198.
Quantity in commerce: 4
Distribution: US Nationwide Distribution
Product codes and lots: Model/Serial Number/s: 00925, 00945, and 00949, 1136

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2056-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2056-2019	Class II	Terminated	FDA Mandated	2019-08-07	2019-07-30

Product code JAA

K180589Class IIDR 800 with MUSICA DynamicAgfa Healthcare N.V. / cleared 2018-04-05

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)