Z-2202-2020Class II

AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic, Type number: 6010/200 -

Name: Z-2202-2020 AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic, Type number: 6010/200 -
Creator: Agfa N.V.
Published: 2020-04-06
License: https://open.fda.gov/license/

Agfa N.V. / initiated 2020-04-06 / Terminated / root cause: software

FDA source

Agfa N.V. began a recall of AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic, Type number: 6010/200 - Product Usage: DR 800: Agfa s DR 800 system is indicated for... on 2020-04-06. FDA classified it as Class II and gives the reason as "Under specific conditions (Fluoroscopic exam, ABS=OFF, manual change of parameters) wrong calculation of the dose/minute for fluoroscopy exams can be possible". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2202-2020
Classification: Class II
Status: Terminated
Initiated: 2020-04-06
Posted: 2020-06-03
Terminated: 2023-04-03
Recalling firm: Agfa N.V.
Product: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic, Type number: 6010/200 - Product Usage: DR 800: Agfa s DR 800 system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence) of the following 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: Under specific conditions (Fluoroscopic exam, ABS=OFF, manual change of parameters) wrong calculation of the dose/minute for fluoroscopy exams can be possible
Root cause tag: software
FDA root cause: Software design
Action: Agfa issued Urgent Field Safety Notice via email on 4/21/20 to consignees, letter states reason for recall, health risk and action to take: Acknowledgment, via a feedback form or email, that the information was received and understood was requested from the consignees.
Quantity in commerce: 13 units
Distribution: US Nationwide distribution including in the sates of FL, IL, IN, LA, MA, MO, OH, SC, VA, WI.
Product codes and lots: Serial Numbers: 0925, 0945, 0948, 0949, 1003, 1022, 1116, 1136, 1161, 1229, 1239, 1401, and 1404

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2202-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2202-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-10	2020-06-03

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)