Z-1487-2013Class II

AGFA Digital Radiography X-Ray System DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic...

Name: Z-1487-2013 AGFA Digital Radiography X-Ray System DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic...
Creator: AGFA Corp.
Published: 2013-05-15
License: https://open.fda.gov/license/

AGFA Healthcare Corp. / initiated 2013-05-15 / Terminated

FDA source

AGFA Corp. began a recall of AGFA Digital Radiography X-Ray System DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis... on 2013-05-15. FDA classified it as Class II and gives the reason as "Customers could potentially experience intermittent, unintended and illogical movement when using the product". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1487-2013
Classification: Class II
Status: Terminated
Initiated: 2013-05-15
Posted: 2013-06-06
Terminated: 2014-12-31
Recalling firm: AGFA Healthcare Corp.
Product: AGFA Digital Radiography X-Ray System DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spinal column and extremities: chest, abdomen, and other body parts.
Product code: IZL System, X-Ray, Mobile
Reason for recall: Customers could potentially experience intermittent, unintended and illogical movement when using the product.
FDA root cause: Under Investigation by firm
Action: Agfa sent an "URGENT SAFETY NOTICE" letter dated May 15, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. Customers were instructed if you experience unintended movement, the unit has to be taken out of operation. Please notify you Agfa service contact at once. Please distribute this information within your facility to all those who need to be aware of this. Please complete the feedback form as soon as possible and return to us. For further questions please call 1-877-777-2432.
Quantity in commerce: 104
Distribution: Worldwide Distribution - US Nationwide including the states of AL, FL, IL, IN, IA, KY, MA, MI, MN, MS, MO, NE, NJ, NY, NC, OH, OR, SC, TN, VA, WV, WY and the country of Canada
Product codes and lots: Material numbers in US - 5Q82F, 5R75Q, 5Q8ZB, 5R77U & 58Q1D - Material numbers in Canada - 5R78W & 5R77U

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1487-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1487-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-12	2013-06-06

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)