Z-2176-2014Class III

Agfa Digital Radiography X-Ray System DX-D 100

Name: Z-2176-2014 Agfa Digital Radiography X-Ray System DX-D 100
Creator: AGFA Healthcare Corp.
Published: 2014-05-13
License: https://open.fda.gov/license/

AGFA Healthcare Corp. / initiated 2014-05-13 / Terminated / root cause: labeling and UDI

FDA source

AGFA Healthcare Corp. began a recall of Agfa Digital Radiography X-Ray System DX-D 100 Product Usage: Is indicated for use in providing diagnostic quality images to aid the physician with diagnoses on 2014-05-13. FDA classified it as Class III and gives the reason as "Unit was mislabeled with a factory label showing 32 KW output power". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2176-2014
Classification: Class III
Status: Terminated
Initiated: 2014-05-13
Posted: 2014-08-10
Terminated: 2014-08-13
Recalling firm: AGFA Healthcare Corp.
Product: Agfa Digital Radiography X-Ray System DX-D 100 Product Usage: Is indicated for use in providing diagnostic quality images to aid the physician with diagnoses.
Product code: IZL System, X-Ray, Mobile
Reason for recall: Unit was mislabeled with a factory label showing 32 KW output power.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Only one customer was affected no customer letter was issued field correction was conducted..
Quantity in commerce: 1
Distribution: US in the state of WV
Product codes and lots: Serial Number A5410000042

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2176-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2176-2014	Class III	Terminated	Voluntary: Firm initiated	2014-08-20	2014-08-09

Product code IZL

K103597Class IIDx-D 100Agfa Healthcare N.V. / cleared 2011-01-03

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)